Trial Outcomes & Findings for Evaluation of the Healthy Love Workshop, an HIV Prevention Intervention for African American Women (NCT NCT00362375)
NCT ID: NCT00362375
Last Updated: 2010-05-14
Results Overview
Percentage of women who used condoms during vaginal intercourse with any male partner during the past 3 months
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
313 participants
Primary outcome timeframe
Past 3 months
Results posted on
2010-05-14
Participant Flow
Information about the study was disseminated through print media, public service announcements on local radio stations, electronic communication and informational mailings to local AIDS service organizations, county health departments, medical clinics, and community centers.
28 groups did not participate for logistical reasons, including lack of follow-up by group contact (10 groups), failure of women to arrive for the workshop (7 groups), and too few women to meet minimum workshop size (6 groups). Five groups did not participate because of insufficient interest by their members in receiving either workshop.
Participant milestones
| Measure |
Healthy Love Workshop
The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
|
HIV101
The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
|
|---|---|---|
|
Overall Study
STARTED
|
161
|
152
|
|
Overall Study
COMPLETED
|
121
|
117
|
|
Overall Study
NOT COMPLETED
|
40
|
35
|
Reasons for withdrawal
| Measure |
Healthy Love Workshop
The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
|
HIV101
The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
40
|
35
|
Baseline Characteristics
Evaluation of the Healthy Love Workshop, an HIV Prevention Intervention for African American Women
Baseline characteristics by cohort
| Measure |
Healthy Love Workshop
n=161 Participants
The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
|
HIV101
n=152 Participants
The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
|
Total
n=313 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
29.1 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
33.7 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
31.3 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
161 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
313 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
161 participants
n=5 Participants
|
152 participants
n=7 Participants
|
313 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Past 3 monthsPopulation: Women who were sexually active at 3-month follow-up and who provided data on outcome measure
Percentage of women who used condoms during vaginal intercourse with any male partner during the past 3 months
Outcome measures
| Measure |
Healthy Love Workshop
n=93 Participants
The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
|
HIV101
n=94 Participants
The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
|
|---|---|---|
|
Condom Use During Vaginal Sex With Any Male Partner
|
59.3 Percent
|
39.6 Percent
|
SECONDARY outcome
Timeframe: Past 3 monthsPopulation: Based on the number of women who provided data at the 3-month follow-up
Percentage of women who reported testing for HIV infection and received their test results during the past 3 months
Outcome measures
| Measure |
Healthy Love Workshop
n=116 Participants
The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
|
HIV101
n=116 Participants
The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
|
|---|---|---|
|
HIV Testing and Receipt of Results
|
20.2 Percent
|
16.3 Percent
|
SECONDARY outcome
Timeframe: currentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: currentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: currentOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Past 3 monthsPopulation: Based on the number of women who provided valid data at the 3-month follow-up
The percentage of women who did not engage in vaginal, oral or anal sexual intercourse with male partners
Outcome measures
| Measure |
Healthy Love Workshop
n=93 Participants
The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
|
HIV101
n=94 Participants
The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
|
|---|---|---|
|
Sexual Abstinence
|
36.6 Percent
|
43.6 Percent
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Past 3 monthsPopulation: Based on the number of women who provided valid data at the 3-month follow-up
The percentage of women who engaged in unprotected vaginal sex (i.e., did not use a condom) with any male partner during the past 3 months
Outcome measures
| Measure |
Healthy Love Workshop
n=93 Participants
The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
|
HIV101
n=94 Participants
The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
|
|---|---|---|
|
Unprotected Vaginal Sex With Any Male Partner
|
37.6 Percent
|
36.2 Percent
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Past 3 monthsPopulation: Based on the number of women who provided valid data at the 3-month follow-up
The number of male sex partners during the past 3 months
Outcome measures
| Measure |
Healthy Love Workshop
n=93 Participants
The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
|
HIV101
n=94 Participants
The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
|
|---|---|---|
|
Number of Male Sex Partners
|
0.70 Number of sex partners
Standard Deviation 0.60
|
0.67 Number of sex partners
Standard Deviation 0.74
|
Adverse Events
Healthy Love Workshop
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV101
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dazon Dixon-Diallo, Executive Director
SisterLove, Inc.
Phone: 404-505-7777
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place