Trial Outcomes & Findings for A Gender-Enhanced Pre-Exposure Prophylaxis (PrEP) Information-Motivational Workshop for Young South African Women (NCT NCT04833127)
NCT ID: NCT04833127
Last Updated: 2024-09-23
Results Overview
Percent of all participants who request and undergo an individual counseling session with the study nurse about the possibility of taking up PrEP. This behavioral measure will be documented by the study nurse
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
100 participants
Primary outcome timeframe
Immediate post-intervention up to 3 months after the intervention (i.e., as reported on the 3-month follow-up and nurse counselor log)
Results posted on
2024-09-23
Participant Flow
Met the goal
Unit of analysis: Recruitment seed
Participant milestones
| Measure |
Masibambane - Gender-Enhanced
A virtual (online) group-based interactive Gender-Enhanced (GE) Workshop (using the WhatsApp® platform). The intervention has components that are conducted by participants on their own time as well as a "real-time" "live" interactive session.
Gender-Enhanced -- Masibambane: The intervention has components that provide PrEP information, provide information about HIV prevention and contraceptive options, prompt women to think about why they may be at risk for HIV, discuss women's sexual rights, and discuss how women can talk to their male partners about PrEP. The components are conducted by participants on their own time as well as during a "real-time" "live" interactive session with trained facilitators.
|
Individually Accessed
In this condition women are given access to a PrEP video and to websites that provide information on PrEP and on contraception options.
Individually accessed: The intervention includes an individually-accessed online PrEP video and South African government websites on PrEP and on contraception options
|
|---|---|---|
|
Overall Study
STARTED
|
50 8
|
50 8
|
|
Overall Study
COMPLETED
|
49 8
|
49 8
|
|
Overall Study
NOT COMPLETED
|
1 0
|
1 0
|
Reasons for withdrawal
| Measure |
Masibambane - Gender-Enhanced
A virtual (online) group-based interactive Gender-Enhanced (GE) Workshop (using the WhatsApp® platform). The intervention has components that are conducted by participants on their own time as well as a "real-time" "live" interactive session.
Gender-Enhanced -- Masibambane: The intervention has components that provide PrEP information, provide information about HIV prevention and contraceptive options, prompt women to think about why they may be at risk for HIV, discuss women's sexual rights, and discuss how women can talk to their male partners about PrEP. The components are conducted by participants on their own time as well as during a "real-time" "live" interactive session with trained facilitators.
|
Individually Accessed
In this condition women are given access to a PrEP video and to websites that provide information on PrEP and on contraception options.
Individually accessed: The intervention includes an individually-accessed online PrEP video and South African government websites on PrEP and on contraception options
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Masibambane - Gender-Enhanced
n=50 Participants
A virtual (online) group-based interactive Gender-Enhanced (GE) Workshop (using the WhatsApp® platform). The intervention has components that are conducted by participants on their own time as well as a "real-time" "live" interactive session.
Gender-Enhanced -- Masibambane: The intervention has components that provide PrEP information, provide information about HIV prevention and contraceptive options, prompt women to think about why they may be at risk for HIV, discuss women's sexual rights, and discuss how women can talk to their male partners about PrEP. The components are conducted by participants on their own time as well as during a "real-time" "live" interactive session with trained facilitators.
|
Individually Accessed
n=50 Participants
In this condition women are given access to a PrEP video and to websites that provide information on PrEP and on contraception options.
Individually accessed: The intervention includes an individually-accessed online PrEP video and South African government websites on PrEP and on contraception options
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
23 years
STANDARD_DEVIATION 2 • n=50 Participants
|
22 years
STANDARD_DEVIATION 2 • n=50 Participants
|
22 years
STANDARD_DEVIATION 2 • n=100 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=50 Participants
|
50 Participants
n=50 Participants
|
100 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=100 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Africa
|
50 participants
n=50 Participants
|
50 participants
n=50 Participants
|
100 participants
n=100 Participants
|
PRIMARY outcome
Timeframe: Immediate post-intervention up to 3 months after the intervention (i.e., as reported on the 3-month follow-up and nurse counselor log)Percent of all participants who request and undergo an individual counseling session with the study nurse about the possibility of taking up PrEP. This behavioral measure will be documented by the study nurse
Outcome measures
| Measure |
Masibambane - Gender-Enhanced
n=50 Participants
A virtual (online) group-based interactive Gender-Enhanced (GE) Workshop (using the WhatsApp® platform). The intervention has components that are conducted by participants on their own time as well as a "real-time" "live" interactive session.
Gender-Enhanced -- Masibambane: The intervention has components that provide PrEP information, provide information about HIV prevention and contraceptive options, prompt women to think about why they may be at risk for HIV, discuss women's sexual rights, and discuss how women can talk to their male partners about PrEP. The components are conducted by participants on their own time as well as during a "real-time" "live" interactive session with trained facilitators.
|
Individually Accessed
n=50 Participants
In this condition women are given access to a PrEP video and to websites that provide information on PrEP and on contraception options.
Individually accessed: The intervention includes an individually-accessed online PrEP video and South African government websites on PrEP and on contraception options
|
|---|---|---|
|
Percent of Participants Who Have an Individual Counseling Session About PrEP.
|
28 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Immediate post-intervention up to 3 months after the interventionPercent of all participants who undergo HIV testing and counseling, using self-administered OraQuick, either on her own or with study nurse support. This behavioral measure will be documented by the study nurse.
Outcome measures
| Measure |
Masibambane - Gender-Enhanced
n=50 Participants
A virtual (online) group-based interactive Gender-Enhanced (GE) Workshop (using the WhatsApp® platform). The intervention has components that are conducted by participants on their own time as well as a "real-time" "live" interactive session.
Gender-Enhanced -- Masibambane: The intervention has components that provide PrEP information, provide information about HIV prevention and contraceptive options, prompt women to think about why they may be at risk for HIV, discuss women's sexual rights, and discuss how women can talk to their male partners about PrEP. The components are conducted by participants on their own time as well as during a "real-time" "live" interactive session with trained facilitators.
|
Individually Accessed
n=50 Participants
In this condition women are given access to a PrEP video and to websites that provide information on PrEP and on contraception options.
Individually accessed: The intervention includes an individually-accessed online PrEP video and South African government websites on PrEP and on contraception options
|
|---|---|---|
|
Percent of Participants Who Undergo HIV-testing and Counseling (HCT).
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Immediate post-intervention up to 3 months after the interventionIf participant is PrEP-eligible (HIV-negative) she initiates PrEP. This outcome will be based on self-report.
Outcome measures
| Measure |
Masibambane - Gender-Enhanced
n=50 Participants
A virtual (online) group-based interactive Gender-Enhanced (GE) Workshop (using the WhatsApp® platform). The intervention has components that are conducted by participants on their own time as well as a "real-time" "live" interactive session.
Gender-Enhanced -- Masibambane: The intervention has components that provide PrEP information, provide information about HIV prevention and contraceptive options, prompt women to think about why they may be at risk for HIV, discuss women's sexual rights, and discuss how women can talk to their male partners about PrEP. The components are conducted by participants on their own time as well as during a "real-time" "live" interactive session with trained facilitators.
|
Individually Accessed
n=50 Participants
In this condition women are given access to a PrEP video and to websites that provide information on PrEP and on contraception options.
Individually accessed: The intervention includes an individually-accessed online PrEP video and South African government websites on PrEP and on contraception options
|
|---|---|---|
|
Percent Taking up PrEP
|
8 Participants
|
5 Participants
|
Adverse Events
Masibambane - Gender-Enhanced
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Individually Accessed
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Masibambane - Gender-Enhanced
n=50 participants at risk
A virtual (online) group-based interactive Gender-Enhanced (GE) Workshop (using the WhatsApp® platform). The intervention has components that are conducted by participants on their own time as well as a "real-time" "live" interactive session.
Gender-Enhanced -- Masibambane: The intervention has components that provide PrEP information, provide information about HIV prevention and contraceptive options, prompt women to think about why they may be at risk for HIV, discuss women's sexual rights, and discuss how women can talk to their male partners about PrEP. The components are conducted by participants on their own time as well as during a "real-time" "live" interactive session with trained facilitators.
|
Individually Accessed
n=50 participants at risk
In this condition women are given access to a PrEP video and to websites that provide information on PrEP and on contraception options.
Individually accessed: The intervention includes an individually-accessed online PrEP video and South African government websites on PrEP and on contraception options
|
|---|---|---|
|
General disorders
violence from a partner
|
2.0%
1/50 • up to the last assessment, at 3-months after the intervention.
Adverse events in this study included: 1. Violence or threat of violence to participant due to participating in HIV prevention activities 2. Breach of confidentiality 3. Stigmatization/discrimination due to participating in HIV prevention activities 4. Serious emotional distress
|
0.00%
0/50 • up to the last assessment, at 3-months after the intervention.
Adverse events in this study included: 1. Violence or threat of violence to participant due to participating in HIV prevention activities 2. Breach of confidentiality 3. Stigmatization/discrimination due to participating in HIV prevention activities 4. Serious emotional distress
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Susie Hoffman
NYS Psychiatric Institute and Columbia University
Phone: 718 744 7686
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place