Trial Outcomes & Findings for Love Infection: A Dramatized Story Intervention (Telenovela/Soap Opera) for HIV Prevention (NCT NCT05358366)
NCT ID: NCT05358366
Last Updated: 2024-09-19
Results Overview
Condom use will be measured as the number of sexual episodes (oral, vaginal, or anal intercourse) in which condoms were used with a male partner in the last month.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
baseline up to 4 months
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Infeccion de Amor (Infectious Love)
Participants will view four IA intervention episodes, one per week starting immediately after the baseline survey and orientation.
Participants will receive an email to their preferred email address with a password to access the episode on the IA's website: https://www.infecciondeamor.com. Each 10-minute episode can be watched more than once during the week and presents a situation with notable HIV risk and ways the characters avoided risk (e.g., condom use) or confronted consequences of poor practices (e.g., HIV infection).
Infeccion de Amor (Infectious Love): Infectious Love is a filmed dramatized story (telenovela/soap opera) Infección de Amor (IA), or "Infectious Love" - culturally tailored for US Latinas and delivered online. IA is a four-episode HIV prevention telenovela co-created with Latinas and a community-based participatory and interdisciplinary. Participants have one week window to watch the 10-minute episodes from their preferred device and location.
|
Wait-listed
Participants will receive IA in the same manner as the intervention group.
Participants will start watching the telenovela episodes 4 months after their baseline survey (after T3 survey). Participants will be informed at recruitment of this group condition and the study randomization. During the waiting time, participants will be called on a monthly basis to encourage participation and refer to services if needed.
Infeccion de Amor (Infectious Love): Infectious Love is a filmed dramatized story (telenovela/soap opera) Infección de Amor (IA), or "Infectious Love" - culturally tailored for US Latinas and delivered online. IA is a four-episode HIV prevention telenovela co-created with Latinas and a community-based participatory and interdisciplinary. Participants have one week window to watch the 10-minute episodes from their preferred device and location.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
27
|
|
Overall Study
Completed Follow-Up 1 (Month 1)
|
26
|
26
|
|
Overall Study
Completed Follow-Up 2 (Month 4)
|
25
|
23
|
|
Overall Study
COMPLETED
|
25
|
23
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Love Infection: A Dramatized Story Intervention (Telenovela/Soap Opera) for HIV Prevention
Baseline characteristics by cohort
| Measure |
Infeccion de Amor (Infectious Love)
n=31 Participants
Participants will view four IA intervention episodes, one per week starting immediately after the baseline survey and orientation.
Participants will receive an email to their preferred email address with a password to access the episode on the IA's website: https://www.infecciondeamor.com. Each 10-minute episode can be watched more than once during the week and presents a situation with notable HIV risk and ways the characters avoided risk (e.g., condom use) or confronted consequences of poor practices (e.g., HIV infection).
|
Wait-listed
n=27 Participants
Participants will receive IA in the same manner as the intervention group.
Participants will start watching the telenovela episodes 4 months after their baseline survey (after T3 survey). Participants will be informed at recruitment of this group condition and the study randomization. During the waiting time, participants will be called on a monthly basis to encourage participation and refer to services if needed.
Infeccion de Amor (Infectious Love): Infectious Love is a filmed dramatized story (telenovela/soap opera) Infección de Amor (IA), or "Infectious Love" - culturally tailored for US Latinas and delivered online. IA is a four-episode HIV prevention telenovela co-created with Latinas and a community-based participatory and interdisciplinary. Participants have one week window to watch the 10-minute episodes from their preferred device and location.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.26 years
n=5 Participants
|
36.37 years
n=7 Participants
|
34.71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline up to 4 monthsPopulation: No Infeccion de Amor (Infectious Love) participants reported engaging in anal intercourse at baseline. Month 1 data are reported for those in this group who completed Follow-Up 1 assessment (immediately after intervention period completion). Wait-listed participants completed Month 1 assessment before watching intervention (4 months after baseline). Month 4 data are reported for each arm for those who completed the second Follow-Up.
Condom use will be measured as the number of sexual episodes (oral, vaginal, or anal intercourse) in which condoms were used with a male partner in the last month.
Outcome measures
| Measure |
Infeccion de Amor (Infectious Love)
n=31 Participants
Participants will view four IA intervention episodes, one per week starting immediately after the baseline survey and orientation.
Participants will receive an email to their preferred email address with a password to access the episode on the IA's website: https://www.infecciondeamor.com. Each 10-minute episode can be watched more than once during the week and presents a situation with notable HIV risk and ways the characters avoided risk (e.g., condom use) or confronted consequences of poor practices (e.g., HIV infection).
|
Wait-listed
n=27 Participants
Participants will receive IA in the same manner as the intervention group.
Participants will start watching the telenovela episodes 4 months after their baseline survey (after T3 survey). Participants will be informed at recruitment of this group condition and the study randomization. During the waiting time, participants will be called on a monthly basis to encourage participation and refer to services if needed.
Infeccion de Amor (Infectious Love): Infectious Love is a filmed dramatized story (telenovela/soap opera) Infección de Amor (IA), or "Infectious Love" - culturally tailored for US Latinas and delivered online. IA is a four-episode HIV prevention telenovela co-created with Latinas and a community-based participatory and interdisciplinary. Participants have one week window to watch the 10-minute episodes from their preferred device and location.
|
|---|---|---|
|
Mean Condom Use
Baseline Oral
|
0.50 sexual episodes
Standard Deviation 1.414
|
0.14 sexual episodes
Standard Deviation 0.535
|
|
Mean Condom Use
Baseline Vaginal
|
1.30 sexual episodes
Standard Deviation 2.562
|
0.52 sexual episodes
Standard Deviation 1.159
|
|
Mean Condom Use
Baseline Anal Intercourse
|
—
|
0 sexual episodes
Standard Deviation 0
|
|
Mean Condom Use
Month 1 Oral
|
0 sexual episodes
Standard Deviation 0
|
1.25 sexual episodes
Standard Deviation 2.927
|
|
Mean Condom Use
Month 1 Vaginal
|
1.50 sexual episodes
Standard Deviation 2.526
|
1.43 sexual episodes
Standard Deviation 2.243
|
|
Mean Condom Use
Month 1 Anal Intercourse
|
0 sexual episodes
Standard Deviation 0
|
3.00 sexual episodes
Standard Deviation 0
|
|
Mean Condom Use
Month 4 Oral
|
0 sexual episodes
Standard Deviation 0
|
0.09 sexual episodes
Standard Deviation 0.302
|
|
Mean Condom Use
Month 4 Vaginal
|
2.25 sexual episodes
Standard Deviation 2.933
|
1.75 sexual episodes
Standard Deviation 3.768
|
|
Mean Condom Use
Month 4 Anal Intercourse
|
0 sexual episodes
Standard Deviation 0
|
0 sexual episodes
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Baseline up to 4 monthsPopulation: Data are reported for all participants who reported this information.
Changes in PrEP awareness will be measured as the number of participants who self-report whether they know about PrEP medication (dichotomous question: yes/no)
Outcome measures
| Measure |
Infeccion de Amor (Infectious Love)
n=31 Participants
Participants will view four IA intervention episodes, one per week starting immediately after the baseline survey and orientation.
Participants will receive an email to their preferred email address with a password to access the episode on the IA's website: https://www.infecciondeamor.com. Each 10-minute episode can be watched more than once during the week and presents a situation with notable HIV risk and ways the characters avoided risk (e.g., condom use) or confronted consequences of poor practices (e.g., HIV infection).
|
Wait-listed
n=27 Participants
Participants will receive IA in the same manner as the intervention group.
Participants will start watching the telenovela episodes 4 months after their baseline survey (after T3 survey). Participants will be informed at recruitment of this group condition and the study randomization. During the waiting time, participants will be called on a monthly basis to encourage participation and refer to services if needed.
Infeccion de Amor (Infectious Love): Infectious Love is a filmed dramatized story (telenovela/soap opera) Infección de Amor (IA), or "Infectious Love" - culturally tailored for US Latinas and delivered online. IA is a four-episode HIV prevention telenovela co-created with Latinas and a community-based participatory and interdisciplinary. Participants have one week window to watch the 10-minute episodes from their preferred device and location.
|
|---|---|---|
|
Number of Participants Who Report Change in PrEP Awareness
Baseline-Yes
|
7 Participants
|
2 Participants
|
|
Number of Participants Who Report Change in PrEP Awareness
Baseline-No
|
24 Participants
|
25 Participants
|
|
Number of Participants Who Report Change in PrEP Awareness
Month 1-Yes
|
20 Participants
|
1 Participants
|
|
Number of Participants Who Report Change in PrEP Awareness
Month 1-No
|
6 Participants
|
23 Participants
|
|
Number of Participants Who Report Change in PrEP Awareness
Month 4-Yes
|
16 Participants
|
2 Participants
|
|
Number of Participants Who Report Change in PrEP Awareness
Month 4-No
|
9 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: baseline to 4 monthsPopulation: The Overall Number of Participants Analyzed reflects the number of unique participants who provided data for any single timepoint. Participants were asked to provide a response at each timepoint although some participants did not provide a response each time they were asked. Data are reported for all responses received.
Changes in PrEP access will be measured as the number of participants who report that they have access to PrEP (Possible responses: yes/no/don't know). Those participants who answered "Yes" to the PrEP awareness question were asked if they have access to PrEP.
Outcome measures
| Measure |
Infeccion de Amor (Infectious Love)
n=22 Participants
Participants will view four IA intervention episodes, one per week starting immediately after the baseline survey and orientation.
Participants will receive an email to their preferred email address with a password to access the episode on the IA's website: https://www.infecciondeamor.com. Each 10-minute episode can be watched more than once during the week and presents a situation with notable HIV risk and ways the characters avoided risk (e.g., condom use) or confronted consequences of poor practices (e.g., HIV infection).
|
Wait-listed
n=4 Participants
Participants will receive IA in the same manner as the intervention group.
Participants will start watching the telenovela episodes 4 months after their baseline survey (after T3 survey). Participants will be informed at recruitment of this group condition and the study randomization. During the waiting time, participants will be called on a monthly basis to encourage participation and refer to services if needed.
Infeccion de Amor (Infectious Love): Infectious Love is a filmed dramatized story (telenovela/soap opera) Infección de Amor (IA), or "Infectious Love" - culturally tailored for US Latinas and delivered online. IA is a four-episode HIV prevention telenovela co-created with Latinas and a community-based participatory and interdisciplinary. Participants have one week window to watch the 10-minute episodes from their preferred device and location.
|
|---|---|---|
|
Number of Participants Who Report Change in PrEP Access
Baseline-Yes
|
2 Participants
|
0 Participants
|
|
Number of Participants Who Report Change in PrEP Access
Baseline-No
|
4 Participants
|
1 Participants
|
|
Number of Participants Who Report Change in PrEP Access
Baseline-Don't Know
|
1 Participants
|
1 Participants
|
|
Number of Participants Who Report Change in PrEP Access
Month 1-Yes
|
2 Participants
|
0 Participants
|
|
Number of Participants Who Report Change in PrEP Access
Month 1-No
|
9 Participants
|
0 Participants
|
|
Number of Participants Who Report Change in PrEP Access
Month 1--Don't Know
|
9 Participants
|
1 Participants
|
|
Number of Participants Who Report Change in PrEP Access
Month 4-Yes
|
5 Participants
|
0 Participants
|
|
Number of Participants Who Report Change in PrEP Access
Month 4-No
|
4 Participants
|
1 Participants
|
|
Number of Participants Who Report Change in PrEP Access
Month 4--Don't Know
|
7 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: baseline to 4 monthsPopulation: The Overall Number of Participants Analyzed reflects the number of unique participants who provided data for any single timepoint. Participants were asked to provide a response at each timepoint although some participants did not provide a response each time they were asked. Data are reported for all responses received.
Changes in PrEP use will be measured as the number of participants who report that they have used PrEP (dichotomous question: yes/no). Those participants who answered "Yes" to the PrEP awareness question were asked about PrEP use.
Outcome measures
| Measure |
Infeccion de Amor (Infectious Love)
n=22 Participants
Participants will view four IA intervention episodes, one per week starting immediately after the baseline survey and orientation.
Participants will receive an email to their preferred email address with a password to access the episode on the IA's website: https://www.infecciondeamor.com. Each 10-minute episode can be watched more than once during the week and presents a situation with notable HIV risk and ways the characters avoided risk (e.g., condom use) or confronted consequences of poor practices (e.g., HIV infection).
|
Wait-listed
n=4 Participants
Participants will receive IA in the same manner as the intervention group.
Participants will start watching the telenovela episodes 4 months after their baseline survey (after T3 survey). Participants will be informed at recruitment of this group condition and the study randomization. During the waiting time, participants will be called on a monthly basis to encourage participation and refer to services if needed.
Infeccion de Amor (Infectious Love): Infectious Love is a filmed dramatized story (telenovela/soap opera) Infección de Amor (IA), or "Infectious Love" - culturally tailored for US Latinas and delivered online. IA is a four-episode HIV prevention telenovela co-created with Latinas and a community-based participatory and interdisciplinary. Participants have one week window to watch the 10-minute episodes from their preferred device and location.
|
|---|---|---|
|
Number of Participants Who Report Changes in PrEP Use
Baseline-Yes
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Report Changes in PrEP Use
Baseline-No
|
7 Participants
|
2 Participants
|
|
Number of Participants Who Report Changes in PrEP Use
Month 1-Yes
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Report Changes in PrEP Use
Month 1-No
|
20 Participants
|
1 Participants
|
|
Number of Participants Who Report Changes in PrEP Use
Month 4-Yes
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Report Changes in PrEP Use
Month 4-No
|
16 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: baseline up to 4 monthsPopulation: This question was only asked of participants who indicated having had a previous HIV test within 30 days before study entry.
Changes in HIV testing will be measured as the number of participants who reported to have been tested for HIV in the last month.
Outcome measures
| Measure |
Infeccion de Amor (Infectious Love)
n=25 Participants
Participants will view four IA intervention episodes, one per week starting immediately after the baseline survey and orientation.
Participants will receive an email to their preferred email address with a password to access the episode on the IA's website: https://www.infecciondeamor.com. Each 10-minute episode can be watched more than once during the week and presents a situation with notable HIV risk and ways the characters avoided risk (e.g., condom use) or confronted consequences of poor practices (e.g., HIV infection).
|
Wait-listed
n=24 Participants
Participants will receive IA in the same manner as the intervention group.
Participants will start watching the telenovela episodes 4 months after their baseline survey (after T3 survey). Participants will be informed at recruitment of this group condition and the study randomization. During the waiting time, participants will be called on a monthly basis to encourage participation and refer to services if needed.
Infeccion de Amor (Infectious Love): Infectious Love is a filmed dramatized story (telenovela/soap opera) Infección de Amor (IA), or "Infectious Love" - culturally tailored for US Latinas and delivered online. IA is a four-episode HIV prevention telenovela co-created with Latinas and a community-based participatory and interdisciplinary. Participants have one week window to watch the 10-minute episodes from their preferred device and location.
|
|---|---|---|
|
Number of Participants Who Report Change in HIV Testing
Baseline-Yes
|
6 Participants
|
3 Participants
|
|
Number of Participants Who Report Change in HIV Testing
Baseline-No
|
19 Participants
|
21 Participants
|
|
Number of Participants Who Report Change in HIV Testing
Month 1-Yes
|
3 Participants
|
2 Participants
|
|
Number of Participants Who Report Change in HIV Testing
Month 1-No
|
20 Participants
|
15 Participants
|
|
Number of Participants Who Report Change in HIV Testing
Month 4-Yes
|
3 Participants
|
4 Participants
|
|
Number of Participants Who Report Change in HIV Testing
Month 4-No
|
21 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: baseline up to 4 monthsPopulation: Participants were asked to complete the HIV Test Perception Score at each timepoint although some participants did not do so each time. Data are reported for all completed questionnaires.
Changes in HIV testing perception will be measured with the willingness to take an HIV test measure scale. Scores range from 9-45. A higher score represents a higher willingness to take an HIV test.
Outcome measures
| Measure |
Infeccion de Amor (Infectious Love)
n=31 Participants
Participants will view four IA intervention episodes, one per week starting immediately after the baseline survey and orientation.
Participants will receive an email to their preferred email address with a password to access the episode on the IA's website: https://www.infecciondeamor.com. Each 10-minute episode can be watched more than once during the week and presents a situation with notable HIV risk and ways the characters avoided risk (e.g., condom use) or confronted consequences of poor practices (e.g., HIV infection).
|
Wait-listed
n=27 Participants
Participants will receive IA in the same manner as the intervention group.
Participants will start watching the telenovela episodes 4 months after their baseline survey (after T3 survey). Participants will be informed at recruitment of this group condition and the study randomization. During the waiting time, participants will be called on a monthly basis to encourage participation and refer to services if needed.
Infeccion de Amor (Infectious Love): Infectious Love is a filmed dramatized story (telenovela/soap opera) Infección de Amor (IA), or "Infectious Love" - culturally tailored for US Latinas and delivered online. IA is a four-episode HIV prevention telenovela co-created with Latinas and a community-based participatory and interdisciplinary. Participants have one week window to watch the 10-minute episodes from their preferred device and location.
|
|---|---|---|
|
Mean Change in HIV Test Perception Score
Baseline
|
34.7 score on a scale
Standard Deviation 3.83
|
35.7 score on a scale
Standard Deviation 4.07
|
|
Mean Change in HIV Test Perception Score
Month 1
|
34.6 score on a scale
Standard Deviation 3.37
|
36.4 score on a scale
Standard Deviation 3.25
|
|
Mean Change in HIV Test Perception Score
Month 4
|
32.8 score on a scale
Standard Deviation 5.82
|
36.1 score on a scale
Standard Deviation 4.33
|
SECONDARY outcome
Timeframe: baseline up to 4 monthsPopulation: Participants were asked to complete the Substance Abuse Behaviors Scale at each timepoint although some participants did not do so each time. Data are reported for all completed questionnaires.
Changes in substance abuse will be measured with the Substance abuse behaviors scale. Scores range from 0-35. A higher score represents a higher use of substances.
Outcome measures
| Measure |
Infeccion de Amor (Infectious Love)
n=31 Participants
Participants will view four IA intervention episodes, one per week starting immediately after the baseline survey and orientation.
Participants will receive an email to their preferred email address with a password to access the episode on the IA's website: https://www.infecciondeamor.com. Each 10-minute episode can be watched more than once during the week and presents a situation with notable HIV risk and ways the characters avoided risk (e.g., condom use) or confronted consequences of poor practices (e.g., HIV infection).
|
Wait-listed
n=27 Participants
Participants will receive IA in the same manner as the intervention group.
Participants will start watching the telenovela episodes 4 months after their baseline survey (after T3 survey). Participants will be informed at recruitment of this group condition and the study randomization. During the waiting time, participants will be called on a monthly basis to encourage participation and refer to services if needed.
Infeccion de Amor (Infectious Love): Infectious Love is a filmed dramatized story (telenovela/soap opera) Infección de Amor (IA), or "Infectious Love" - culturally tailored for US Latinas and delivered online. IA is a four-episode HIV prevention telenovela co-created with Latinas and a community-based participatory and interdisciplinary. Participants have one week window to watch the 10-minute episodes from their preferred device and location.
|
|---|---|---|
|
Mean Change in Substance Abuse Score
Baseline
|
2.42 score on a scale
Standard Deviation 3.65
|
0.78 score on a scale
Standard Deviation 1.09
|
|
Mean Change in Substance Abuse Score
Month 1
|
2.32 score on a scale
Standard Deviation 3.78
|
0.96 score on a scale
Standard Deviation 1.30
|
|
Mean Change in Substance Abuse Score
Month 4
|
2.75 score on a scale
Standard Deviation 3.67
|
1.23 score on a scale
Standard Deviation 2.86
|
SECONDARY outcome
Timeframe: baseline up to 4 monthsPopulation: Participants were asked to complete the IPV at each timepoint although some participants did not do so each time. Data are reported for all completed questionnaires.
Changes in IPV measured using the revised Conflict Tactics Scale to measure women's self-reported IPV in the previous 3 months (e.g., your partner insulted you). Scores range from 0-36 points. A higher score indicates higher levels of IPV.
Outcome measures
| Measure |
Infeccion de Amor (Infectious Love)
n=30 Participants
Participants will view four IA intervention episodes, one per week starting immediately after the baseline survey and orientation.
Participants will receive an email to their preferred email address with a password to access the episode on the IA's website: https://www.infecciondeamor.com. Each 10-minute episode can be watched more than once during the week and presents a situation with notable HIV risk and ways the characters avoided risk (e.g., condom use) or confronted consequences of poor practices (e.g., HIV infection).
|
Wait-listed
n=27 Participants
Participants will receive IA in the same manner as the intervention group.
Participants will start watching the telenovela episodes 4 months after their baseline survey (after T3 survey). Participants will be informed at recruitment of this group condition and the study randomization. During the waiting time, participants will be called on a monthly basis to encourage participation and refer to services if needed.
Infeccion de Amor (Infectious Love): Infectious Love is a filmed dramatized story (telenovela/soap opera) Infección de Amor (IA), or "Infectious Love" - culturally tailored for US Latinas and delivered online. IA is a four-episode HIV prevention telenovela co-created with Latinas and a community-based participatory and interdisciplinary. Participants have one week window to watch the 10-minute episodes from their preferred device and location.
|
|---|---|---|
|
Mean Change in Intimate Partner Violence (IPV) Score
Baseline
|
2.27 score on a scale
Standard Deviation 3.52
|
2.78 score on a scale
Standard Deviation 4.57
|
|
Mean Change in Intimate Partner Violence (IPV) Score
Month 1
|
2.28 score on a scale
Standard Deviation 5.56
|
1.96 score on a scale
Standard Deviation 3.26
|
|
Mean Change in Intimate Partner Violence (IPV) Score
Month 4
|
1.79 score on a scale
Standard Deviation 3.72
|
1.25 score on a scale
Standard Deviation 1.83
|
SECONDARY outcome
Timeframe: baseline up to 4 monthsPopulation: Participants were asked to complete the PHQ-9 at each timepoint although some participants did not do so each time. Data are reported for all completed questionnaires.
Changes in depression will be measured with the Patient Health Questionnaire (PHQ-9), a 9-item scale commonly used for depression screening in primary care and other health settings. Scores range from 0-27. A higher score indicates more depressive symptoms.
Outcome measures
| Measure |
Infeccion de Amor (Infectious Love)
n=31 Participants
Participants will view four IA intervention episodes, one per week starting immediately after the baseline survey and orientation.
Participants will receive an email to their preferred email address with a password to access the episode on the IA's website: https://www.infecciondeamor.com. Each 10-minute episode can be watched more than once during the week and presents a situation with notable HIV risk and ways the characters avoided risk (e.g., condom use) or confronted consequences of poor practices (e.g., HIV infection).
|
Wait-listed
n=27 Participants
Participants will receive IA in the same manner as the intervention group.
Participants will start watching the telenovela episodes 4 months after their baseline survey (after T3 survey). Participants will be informed at recruitment of this group condition and the study randomization. During the waiting time, participants will be called on a monthly basis to encourage participation and refer to services if needed.
Infeccion de Amor (Infectious Love): Infectious Love is a filmed dramatized story (telenovela/soap opera) Infección de Amor (IA), or "Infectious Love" - culturally tailored for US Latinas and delivered online. IA is a four-episode HIV prevention telenovela co-created with Latinas and a community-based participatory and interdisciplinary. Participants have one week window to watch the 10-minute episodes from their preferred device and location.
|
|---|---|---|
|
Mean Change in Depression (PHQ-9) Score
Baseline
|
5.61 score on a scale
Standard Deviation 3.97
|
4.04 score on a scale
Standard Deviation 4.05
|
|
Mean Change in Depression (PHQ-9) Score
Month 1
|
5.65 score on a scale
Standard Deviation 4.36
|
2.29 score on a scale
Standard Deviation 3.34
|
|
Mean Change in Depression (PHQ-9) Score
Month 4
|
6.67 score on a scale
Standard Deviation 6.40
|
2.36 score on a scale
Standard Deviation 2.92
|
SECONDARY outcome
Timeframe: immediately after watching each 10-minute weekly episode for up to 4 weeksThe online website will track if the 40-minutes of the intervention content is viewed and the number of participants who complete of all content will be calculated.
Outcome measures
| Measure |
Infeccion de Amor (Infectious Love)
n=31 Participants
Participants will view four IA intervention episodes, one per week starting immediately after the baseline survey and orientation.
Participants will receive an email to their preferred email address with a password to access the episode on the IA's website: https://www.infecciondeamor.com. Each 10-minute episode can be watched more than once during the week and presents a situation with notable HIV risk and ways the characters avoided risk (e.g., condom use) or confronted consequences of poor practices (e.g., HIV infection).
|
Wait-listed
n=27 Participants
Participants will receive IA in the same manner as the intervention group.
Participants will start watching the telenovela episodes 4 months after their baseline survey (after T3 survey). Participants will be informed at recruitment of this group condition and the study randomization. During the waiting time, participants will be called on a monthly basis to encourage participation and refer to services if needed.
Infeccion de Amor (Infectious Love): Infectious Love is a filmed dramatized story (telenovela/soap opera) Infección de Amor (IA), or "Infectious Love" - culturally tailored for US Latinas and delivered online. IA is a four-episode HIV prevention telenovela co-created with Latinas and a community-based participatory and interdisciplinary. Participants have one week window to watch the 10-minute episodes from their preferred device and location.
|
|---|---|---|
|
Number of Episodes Watched by Participants
Watched 0 Episodes
|
2 Participants
|
18 Participants
|
|
Number of Episodes Watched by Participants
Watched 1 Episodes
|
1 Participants
|
2 Participants
|
|
Number of Episodes Watched by Participants
Watched 2 Episodes
|
2 Participants
|
0 Participants
|
|
Number of Episodes Watched by Participants
Watched 3 Episodes
|
0 Participants
|
0 Participants
|
|
Number of Episodes Watched by Participants
Watched 4 Episodes
|
26 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: baseline up to 4 monthsThe number of participants who completed all study assessment timepoints from start to finish.
Outcome measures
| Measure |
Infeccion de Amor (Infectious Love)
n=31 Participants
Participants will view four IA intervention episodes, one per week starting immediately after the baseline survey and orientation.
Participants will receive an email to their preferred email address with a password to access the episode on the IA's website: https://www.infecciondeamor.com. Each 10-minute episode can be watched more than once during the week and presents a situation with notable HIV risk and ways the characters avoided risk (e.g., condom use) or confronted consequences of poor practices (e.g., HIV infection).
|
Wait-listed
n=27 Participants
Participants will receive IA in the same manner as the intervention group.
Participants will start watching the telenovela episodes 4 months after their baseline survey (after T3 survey). Participants will be informed at recruitment of this group condition and the study randomization. During the waiting time, participants will be called on a monthly basis to encourage participation and refer to services if needed.
Infeccion de Amor (Infectious Love): Infectious Love is a filmed dramatized story (telenovela/soap opera) Infección de Amor (IA), or "Infectious Love" - culturally tailored for US Latinas and delivered online. IA is a four-episode HIV prevention telenovela co-created with Latinas and a community-based participatory and interdisciplinary. Participants have one week window to watch the 10-minute episodes from their preferred device and location.
|
|---|---|---|
|
Number of Participants Who Are Retained Through All Study Timepoints
|
26 Participants
|
23 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: one-month after the baseline surveyParticipants will be asked to rate each of the 9 content area using a 5-star rating system where 1 star is the lowest and 5 points is the highest rating. A mean of all ratings will be calculated. The closer the mean is to 5.0, the higher the satisfaction with the content areas. Scores range from 9-45. A higher score indicates a higher level of acceptability.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline up to 1 monthChanges in Self-Efficacy will be measured using the HIV self-efficacy for condom use survey. Scores range from 7-28. A higher score indicates a higher level of self-efficacy for condom use.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline up to 1 monthChanges in Self-Efficacy will be measured using the HIV self-efficacy for HIV prevention behaviors survey. Scores range from 11-55. A higher score indicates a higher level of self-efficacy for HIV prevention behaviors.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline up to 1 monthNarrative engagement will be measured with the Perception of Narrative Performance Scale, which measures three dimensions of engagement: interest, realism, and identification. Scores range from 9-36. A higher score indicates a higher level of engagement.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline up to 1 monthChanges in emotional Response will be measured with the International Positive and Negative Affect Schedule Short Form (I-PANAS-SF). Scores range from 10-50. The higher scores indicate the tendency to experience a positive and negative mood.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline up to 4 monthsMeasured as the total number of sessions attended by the participants as a whole.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline up to 4 monthsChange in HIV knowledge will be measured via the HIV Knowledge Scale. The score ranges from 0-12 with a higher score indicating a higher level of HIV-related knowledge.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline up to 4 monthsChanges in STI testing will be measured as the number of participants who reported to have been tested for a STI in the last month.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline up to 4 monthsChange in sexual communication with partner will be measured via the Partner communication Scale (Catania et al., 1995). The score ranges from 0-10 with a higher score indicating a higher level of partner communication.
Outcome measures
Outcome data not reported
Adverse Events
Infeccion de Amor (Infectious Love)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait-listed
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
Natalia Villegas Rodriguez, PhD
University of North Carolina at Chapel Hill
Phone: 919-966-4260
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place