Trial Outcomes & Findings for Promoting CSD500 Use Among Women in Established Relationships (NCT NCT02934620)

Results Overview

A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1000 participants

Primary outcome timeframe

Vaginal swab collected at 2-month follow-up visit

Results posted on

2024-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	CSD500 Condom- Male Partners Male and female partners were enrolled at together as a couple in the study. Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Male Partners Male and female partners were enrolled at together as a couple in the study. Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	CSD500 Condom - Female Participants Male and female partners were enrolled at together as a couple in the study. Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Female Participants Male and female partners were enrolled at together as a couple in the study. Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.
Baseline Visit STARTED	248	252	248	252
Baseline Visit COMPLETED	248	252	248	252
Baseline Visit NOT COMPLETED	0	0	0	0
2-month Visit STARTED	0	0	248	252
2-month Visit COMPLETED	0	0	233	228
2-month Visit NOT COMPLETED	0	0	15	24
4-month Visit STARTED	0	0	248	252
4-month Visit COMPLETED	0	0	228	220
4-month Visit NOT COMPLETED	0	0	20	32
6-month Visit STARTED	248	252	248	252
6-month Visit COMPLETED	230	238	234	239
6-month Visit NOT COMPLETED	18	14	14	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age of male partners was not collected.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CSD500 Condom - Female Participants n=248 Participants Male and female partners were enrolled at together as a couple in the study. Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Female Participants n=252 Participants Male and female partners were enrolled at together as a couple in the study. Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	CSD500 Condom - Male Participants n=248 Participants Male and female partners were enrolled at together as a couple in the study. Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Male Participants n=252 Participants Male and female partners were enrolled at together as a couple in the study. Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Total n=1000 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=248 Participants • Age of male partners was not collected.	0 Participants n=252 Participants • Age of male partners was not collected.	—	—	0 Participants n=500 Participants • Age of male partners was not collected.
Age, Categorical Between 18 and 65 years	248 Participants n=248 Participants • Age of male partners was not collected.	252 Participants n=252 Participants • Age of male partners was not collected.	—	—	500 Participants n=500 Participants • Age of male partners was not collected.
Age, Categorical >=65 years	0 Participants n=248 Participants • Age of male partners was not collected.	0 Participants n=252 Participants • Age of male partners was not collected.	—	—	0 Participants n=500 Participants • Age of male partners was not collected.
Age, Continuous	33.9 Years STANDARD_DEVIATION 5.3 • n=248 Participants • Age of male partners was not collected.	34.3 Years STANDARD_DEVIATION 5.5 • n=252 Participants • Age of male partners was not collected.	—	—	34.1 Years STANDARD_DEVIATION 5.4 • n=500 Participants • Age of male partners was not collected.
Sex: Female, Male Female	248 Participants n=248 Participants	252 Participants n=252 Participants	0 Participants n=248 Participants	0 Participants n=252 Participants	500 Participants n=1000 Participants
Sex: Female, Male Male	0 Participants n=248 Participants	0 Participants n=252 Participants	248 Participants n=248 Participants	252 Participants n=252 Participants	500 Participants n=1000 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=248 Participants	0 Participants n=252 Participants	0 Participants n=248 Participants	0 Participants n=252 Participants	0 Participants n=1000 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	248 Participants n=248 Participants	252 Participants n=252 Participants	248 Participants n=248 Participants	252 Participants n=252 Participants	1000 Participants n=1000 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=248 Participants	0 Participants n=252 Participants	0 Participants n=248 Participants	0 Participants n=252 Participants	0 Participants n=1000 Participants
Region of Enrollment Vietnam	248 participants n=248 Participants	252 participants n=252 Participants	248 participants n=248 Participants	252 participants n=252 Participants	1000 participants n=1000 Participants

PRIMARY outcome

Timeframe: Vaginal swab collected at 2-month follow-up visit

Population: Intent-to-treat

A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.

Outcome measures

Outcome measures
Measure	CSD500 Condom - Female Participants n=233 Participants Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Female Participants n=228 Participants Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	CSD500 Condom - Male Participants Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Male Participants Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.
Number of Female Participants With Positive PSA at 2-Month Visit	18 Participants	20 Participants	—	—

PRIMARY outcome

Timeframe: Vaginal swab collected at 4-month follow-up visit

A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.

Outcome measures

Outcome measures
Measure	CSD500 Condom - Female Participants n=228 Participants Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Female Participants n=220 Participants Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	CSD500 Condom - Male Participants Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Male Participants Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.
Number of Female Participants With Positive PSA at 4-Month Visit	12 Participants	12 Participants	—	—

PRIMARY outcome

Timeframe: Vaginal swab collected at 6-month follow-up visit

A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.

Outcome measures

Outcome measures
Measure	CSD500 Condom - Female Participants n=234 Participants Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Female Participants n=239 Participants Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	CSD500 Condom - Male Participants Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Male Participants Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.
Number of Female Participants With Positive PSA at 6-Month Visit	17 Participants	14 Participants	—	—

SECONDARY outcome

Timeframe: Measured at 2-month follow-up visit

Population: Intent-to-treat

Investigators will compare frequency of self-reports of recent sex without a condom between the two arms of female participants.

Outcome measures

Outcome measures
Measure	CSD500 Condom - Female Participants n=233 Participants Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Female Participants n=227 Participants Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	CSD500 Condom - Male Participants Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Male Participants Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.
Number of Female Participants With Self-reported Condomless Sex at 2-month Follow-up Visit	8 Participants	22 Participants	—	—

SECONDARY outcome

Timeframe: Measured among participants at at 6-month follow-up visit

The Quality of Sexual Experience Scale was modified to add a question about pleasure related to the act's duration. The scale will be used to evaluate the effects of CSD500 provision on women and men's reports of sexual pleasure compared to the standard condom. The scale ranges from 0-7 points with a higher score indicating a higher-quality experience.

Outcome measures

Outcome measures
Measure	CSD500 Condom - Female Participants n=233 Participants Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Female Participants n=228 Participants Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	CSD500 Condom - Male Participants n=229 Participants Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Male Participants n=237 Participants Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.
Quality of Sexual Experience (QSE) Scale Scores Among Participants at 6-month Visit	5.27 score on a scale Standard Deviation 0.84	277 score on a scale Standard Deviation 5.13	5.48 score on a scale Standard Deviation 0.79	5.27 score on a scale Standard Deviation 0.66

SECONDARY outcome

Timeframe: Measured among female participants at at 2-month follow-up visit

The Quality of Sexual Experience Scale was modified to add a question about pleasure related to the act's duration. The scale will be used to evaluate the effects of CSD500 provision on women's reports of sexual pleasure compared to the standard condom. The scale ranges from 0-7 points with a higher score indicating a higher-quality experience.

Outcome measures

Outcome measures
Measure	CSD500 Condom - Female Participants n=233 Participants Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Female Participants n=227 Participants Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	CSD500 Condom - Male Participants Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Male Participants Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.
Quality of Sexual Experience (QSE) Scale Scores Among Female Participants at 2-month Visit	5.27 score on a scale Standard Deviation 0.84	5.13 score on a scale Standard Deviation 0.72	—	—

SECONDARY outcome

Timeframe: Measured among female participants at at 4-month follow-up visit

The Quality of Sexual Experience Scale was modified to add a question about pleasure related to the act's duration. The scale will be used to evaluate the effects of CSD500 provision on women's reports of sexual pleasure compared to the standard condom. The scale ranges from 0-7 points with a higher score indicating a higher-quality experience.

Outcome measures

Outcome measures
Measure	CSD500 Condom - Female Participants n=226 Participants Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Female Participants n=220 Participants Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	CSD500 Condom - Male Participants Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Male Participants Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.
Quality of Sexual Experience (QSE) Scale Scores Among Female Participants at 4-month Visit	5.20 score on a scale Standard Deviation 0.71	5.07 score on a scale Standard Deviation 0.70	—	—

SECONDARY outcome

Timeframe: Measured at 4-month follow-up visit

Population: Intent-to-treat

Investigators will compare frequency of self-reports of recent sex without a condom between the two arms of female participants.

Outcome measures

Outcome measures
Measure	CSD500 Condom - Female Participants n=227 Participants Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Female Participants n=220 Participants Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	CSD500 Condom - Male Participants Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Male Participants Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.
Number of Female Participants With Self-reported Condomless Sex at 4-month Follow-up Visit	17 Participants	12 Participants	—	—

SECONDARY outcome

Timeframe: Measured at 6-month follow-up visit

Population: Intent-to-treat

Investigators will compare frequency of self-reports of recent sex without a condom between the two arms of female participants.

Outcome measures

Outcome measures
Measure	CSD500 Condom - Female Participants n=231 Participants Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Female Participants n=238 Participants Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	CSD500 Condom - Male Participants Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Male Participants Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.
Number of Female Participants With Self-reported Condomless Sex at 6-month Follow-up Visit	16 Participants	14 Participants	—	—

Adverse Events

CSD500 Condom - Female Participants

Serious events: 0 serious events

Other events: 68 other events

Deaths: 0 deaths

Standard Condom - Female Participants

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

CSD500 Condom - Male Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Condom -Male Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CSD500 Condom - Female Participants n=240 participants at risk；n=248 participants at risk Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Female Participants n=240 participants at risk；n=252 participants at risk Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	CSD500 Condom - Male Participants n=248 participants at risk Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom -Male Participants n=252 participants at risk Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.
General disorders Headaches at 2-month among Female Participants	17.2% 40/233 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	0.00% 0/227 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	— 0/0 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	— 0/0 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.
General disorders Headaches at 4-month among Female Participants	14.1% 32/227 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	0.00% 0/220 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	— 0/0 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	— 0/0 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.
General disorders Headaches at 6-month among Female Participants	10.3% 24/233 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	0.00% 0/238 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	— 0/0 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	— 0/0 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.
General disorders Dizziness at 2 months among Female Participants	10.3% 24/233 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	0.44% 1/227 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	— 0/0 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	— 0/0 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.
General disorders Dizziness at 4 months among Female Participants	5.3% 12/227 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	0.45% 1/220 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	— 0/0 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	— 0/0 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.

Additional Information

Maria Gallo

Ohio State University, College of Public Health

Phone: 16146882145

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	CSD500 Condom - Female Participants n=240 participants at risk；n=248 participants at risk Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom - Female Participants n=240 participants at risk；n=252 participants at risk Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	CSD500 Condom - Male Participants n=248 participants at risk Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.	Standard Condom -Male Participants n=252 participants at risk Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.
General disorders Headaches at 2-month among Female Participants	17.2% 40/233 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	0.00% 0/227 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	— 0/0 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	— 0/0 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.
General disorders Headaches at 4-month among Female Participants	14.1% 32/227 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	0.00% 0/220 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	— 0/0 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	— 0/0 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.
General disorders Headaches at 6-month among Female Participants	10.3% 24/233 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	0.00% 0/238 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	— 0/0 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	— 0/0 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.
General disorders Dizziness at 2 months among Female Participants	10.3% 24/233 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	0.44% 1/227 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	— 0/0 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	— 0/0 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.
General disorders Dizziness at 4 months among Female Participants	5.3% 12/227 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	0.45% 1/220 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	— 0/0 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.	— 0/0 • 6 months The number of participants at risk for all the adverse event terms are less than the \\Total\\ number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk. Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.