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| Name | Class |
|---|---|
| Medical Research Council, South Africa | OTHER |
| Brown University | OTHER |
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This is a phase 1 pilot study to assess feasibility and acceptability and potential for impact of a gender-enhanced virtual group workshop focused on oral Pre-Exposure Prophylaxis (PrEP) as an HIV prevention method for young South African women. It was developed in collaboration with South African adolescent girls and young women (AGYW) aged 18-25. The investigators compared AGYW (N=100) assigned to the virtual group-based (GE) workshop to those assigned to an Individually Accessed (IA) condition in which women were given access to a PrEP video and to websites that provide information on PrEP and on contraception options. Investigators also evaluated the acceptability and feasibility of participant-driven recruitment (PDR). AGYW assigned to either intervention condition were invited to become Peer Health Advocates (PHAs), who were incentivized to talk to social network members and refer up to three to the intervention type the PHA attended. The aim was to assess if PDR is self-sustaining and is effective at reaching women who might not be reached in clinics.
South African adolescent girls and young women (AGYW) remain at extraordinarily high risk of HIV infection. Oral pre-exposure prophylaxis (PrEP) has the potential to alter the epidemic in this vulnerable population, given that it is has been shown that if it is adhered to, oral PrEP can protect women from HIV infection. Yet, a critical question is whether AGYW will adopt and adhere to oral PrEP.
The investigators propose that two innovations can reach young, at-risk AGYW, inform them about PrEP and motivate them to use it: (1) introducing PrEP through a gender lens in a group workshop; and (2) participant-driven recruitment-recruiting women to attend the workshop by those who have already attended it. To inform intervention development, the investigators conducted six focus groups with sexually-active AGYW (aged 18-25), 8 qualitative interviews with focus group participants, and 20 qualitative interviews with men (10 HIV-positive, 10 HIV-negative or of unknown status) partnered with women in this age range that explored knowledge of, beliefs about, motivators for, and concerns about using PrEP in the context of gendered relationship dynamics and PrEP-related stigma. Guided by gender theory and the Information Motivation Behavior (IMB) model, and in collaboration with a Working Group of AGYW, a virtual (online) group-based Gender-Enhanced (GE) Workshop (using the WhatsApp® platform) was developed. The intervention has components that are conducted by participants on their own time as well as a "real-time" "live" interactive session and aims to provide PrEP information and address AGYW's barriers to using it. The goal of the intervention is to promote consideration of and uptake of PrEP.
In this phase 1 pilot study to assess feasibility and acceptability and potential for impact of the workshop, investigators compared AGYW (N=100) assigned to the virtual group-based (GE) workshop or to an Individually Accessed (IA) condition in which women were given access to a PrEP video and to websites that provide information on PrEP and on contraception options. To evaluate participant-driven recruitment (PDR), AGYW assigned to either condition were invited to become Peer Health Advocates (PHAs), who are incentivized to talk to social network members and refer up to three to the workshop type the PHA attended. Acceptability and feasibility of PDR were evaluated by assessing whether the method can be self-sustaining (i.e., on average >50% attendees become PHAs and >2 recruits/PHAs attend a workshop); and whether it reaches high-risk women and women who would not be captured by other methods of recruitment (percent who score high on HIV risk; percent who never tested or attended family planning). If promising, these approaches will be further tested in a larger study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Masibambane - Gender-Enhanced | Active Comparator | 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. |
|
| Individually accessed | Other | In this condition women are given access to a PrEP video and to websites that provide information on PrEP and on contraception options. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gender-Enhanced -- Masibambane | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants Who Have an Individual Counseling Session About PrEP. | 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 | Immediate post-intervention up to 3 months after the intervention (i.e., as reported on the 3-month follow-up and nurse counselor log) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants Who Undergo HIV-testing and Counseling (HCT). | Percent 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. | Immediate post-intervention up to 3 months after the intervention |
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Inclusion Criteria:
Exclusion Criteria:
Based on self-representation of gender identity
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South African Medical Research Council | Durban | KwaZulu-Natal | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35306944 | Background | Harrison A, Bhengu N, Miller L, Exner T, Tesfay N, Magutshwa S, Khumalo S, Bergam S, Hoffman S, Hanass-Hancock J. "You tell him that 'baby, I am protecting myself'": Women's agency and constraint around willingness to use pre-exposure prophylaxis in the Masibambane Study. Womens Health (Lond). 2022 Jan-Dec;18:17455057221087117. doi: 10.1177/17455057221087117. | |
| 35218452 |
| Label | URL |
|---|---|
| Publically-available website about the study | View source |
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Met the goal
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Participants Who Have an Individual Counseling Session About PrEP. | 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 | Posted | Count of Participants | Participants | Immediate post-intervention up to 3 months after the intervention (i.e., as reported on the 3-month follow-up and nurse counselor log) |
|
up to the last assessment, at 3-months after the intervention.
Adverse events in this study included:
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| violence from a partner | General disorders | Systematic Assessment | Participant reported an instance of intimate partner violence, not related to study participation |
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Pilot trial with sample size of 100 participants, designed to assess feasibility and acceptability rather than efficacy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susie Hoffman | NYS Psychiatric Institute and Columbia University | 718 744 7686 | sh51@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 5, 2022 | Apr 4, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2022 | Apr 4, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 4, 2021 | Apr 4, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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|
| Individually accessed | Behavioral | The intervention includes an individually-accessed online PrEP video and South African government websites on PrEP and on contraception options |
|
| Percent Taking up PrEP | If participant is PrEP-eligible (HIV-negative) she initiates PrEP. This outcome will be based on self-report. | Immediate post-intervention up to 3 months after the intervention |
| Bergam S, Harrison AD, Benghu N, Khumalo S, Tesfay N, Exner T, Miller L, Dolezal C, Hanass-Hancock J, Hoffman S. Women's Perceptions of HIV- and Sexuality-Related Stigma in Relation to PrEP: Qualitative Findings from the Masibambane Study, Durban, South Africa. AIDS Behav. 2022 Sep;26(9):2881-2890. doi: 10.1007/s10461-022-03632-6. Epub 2022 Feb 26. |
| 38416275 | Background | Fordjuoh J, Dolezal C, Bhengu N, Harrison AD, Exner TM, Hanass-Hancock J, Hoffman S. Peer-to-Peer Chain Recruitment for Enrolling Young South African Women into an HIV Pre-exposure Prophylaxis (PrEP) Intervention Study: How Did It Perform? AIDS Behav. 2024 May;28(5):1782-1794. doi: 10.1007/s10461-023-04256-0. Epub 2024 Feb 28. |
| 36735226 | Background | Hanass-Hancock J, Bhengu N, Exner T, Magusthwa S, Harrison A, Dolezal C, Miller L, Bauman L, Hoffman S. Masibambane-Ladies Chat: Developing an Online Gender-Enhanced PrEP Information-Motivation Workshop for Young South African Women. AIDS Educ Prev. 2023 Feb;35(1):14-35. doi: 10.1521/aeap.2023.35.1.14. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
|
|
|
| Secondary | Percent of Participants Who Undergo HIV-testing and Counseling (HCT). | Percent 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. | Posted | Count of Participants | Participants | Immediate post-intervention up to 3 months after the intervention |
|
|
|
|
| Secondary | Percent Taking up PrEP | If participant is PrEP-eligible (HIV-negative) she initiates PrEP. This outcome will be based on self-report. | Posted | Count of Participants | Participants | Immediate post-intervention up to 3 months after the intervention |
|
|
|
|
| 0 |
| 50 |
| 1 |
| 50 |
| 0 |
| 50 |
| EG001 | 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 | 0 | 50 | 0 | 50 | 0 | 50 |
|
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| GLM (logit link) with GEE |
adjusted for baseline differences in age, educational status, and whether has a primary male partner. |
| 0.927 |
GLM (logit link) with GEE to account for clustering by recruitment chain |
| Odds Ratio (OR) |
| .95 |
| 2-Sided |
| 95 |
| 0.31 |
| 2.90 |
| Equivalence |
Null H: No difference between the 2 groups |
| GLM (logit link) with GEE |
GEE used to account for clustering by recruitment chain |
| 0.295 |
| Odds Ratio (OR) |
| 1.64 |
| 2-Sided |
| 95 |
| 0.65 |
| 4.13 |
adjusted for baseline differences in age, education, and whether has a main male partner. |
| Equivalence |
Null hypothesis: No difference between the groups |