HIV InfectionsPhase 1MasibambaneNCT04833127
A Gender-Enhanced Pre-Exposure Prophylaxis (PrEP) Information-Motivational Workshop for Young South African Women
A Phase 1 study testing Gender-Enhanced -- Masibambane and Individually accessed in people with HIV Infections, run by New York State Psychiatric Institute at 1 site in South Africa.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Gender-Enhanced -- Masibambane and Individually accessed
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Africa
- Study dates
- 17 Mar 2021to 31 Dec 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- self-reported HIV-negative or unknown status
- heterosexual vaginal or anal intercourse reported in the past 6 months
- Is not currently taking PrEP or planning to begin PrEP
- presently residing in eThekweni-metropolitan Durban
- has private smart-phone access
- Conversant in isiZulu or English
- Willing to recruit other women (if in first group of participants);
- (If recruited subsequent to first group): Recruited by a peer health advocate (someone the participant knew knew prior to being recruited)
Who cannot join
- Overt signs of cognitive impairment
- Was a participant in the previously conducted focus groups
- If assigned to the online group intervention, unwilling to be audio-recorded
Trial locations and contacts
1 site in 1 country.
South Africa1 site
South African Medical Research Council
Durban, KwaZulu-Natal
About this study
Official title: Developing a Gender-Enhanced Pre-Exposure Prophylaxis (PrEP) Information-Motivational Workshop for Young South African Women
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.
Read the detailed description
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.
- Conditions
- HIV Infections
- Being tested
- Gender-Enhanced -- Masibambane, Individually accessed
- Keywords
- Pre-Exposure Prophylaxis, oral, South African, Adolescent girls and young women, HIV prevention
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gender-Enhanced -- MasibambaneBehavioural
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 accessedBehavioural
The intervention includes an individually-accessed online PrEP video and South African government websites on PrEP and on contraception options
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Gender-Enhanced -- Masibambane |
| 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. Receives: Behavioral: Individually accessed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediate post-intervention up to 3 months after the intervention (i.e., as reported on the 3-month follow-up and nurse counselor log)
Secondary outcomes (2)
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.
Measured: Immediate post-intervention up to 3 months after the intervention
Percent Taking up PrEP
If participant is PrEP-eligible (HIV-negative) she initiates PrEP. This outcome will be based on self-report.
Measured: Immediate post-intervention up to 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start17 Mar 2021
- Primary completion24 Jun 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, South Africa, Brown University
- Responsible party
- Principal investigator, Susie Hoffman, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833127
- Sponsor's protocol ID
- 7682
- Acronym
- Masibambane
- Status last verified
- May 2024
- First submitted
- 21 Mar 2021
- Last updated
- 23 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35306944Bergam 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.
PubMed 35218452Fordjuoh 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.
PubMed 38416275Hanass-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.
PubMed 36735226
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Gender-Enhanced Pre-Exposure Prophylaxis (PrEP) Information-Motivational Workshop for Young South African Women
- ClinicalTrials.gov ID
- NCT04833127
- Acronym / sponsor ID
- Masibambane / 7682
- Conditions
- HIV Infections
- Keywords
- Pre-Exposure Prophylaxis, oral, South African, Adolescent girls and young women, HIV prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Medical Research Council, South Africa, Brown University
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 6 Apr 2021 (actual)
- Results
- Posted 23 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Masibambane - Gender-Enhanced | Active comparator | Behavioral: Gender-Enhanced -- MasibambaneA 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 | Behavioral: Individually accessedIn this condition women are given access to a PrEP video and to websites that provide information on PrEP and on contraception options. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- self-reported HIV-negative or unknown status
- heterosexual vaginal or anal intercourse reported in the past 6 months
- Is not currently taking PrEP or planning to begin PrEP
- presently residing in eThekweni-metropolitan Durban
- has private smart-phone access
Key exclusion criteria (3 listed)
- Overt signs of cognitive impairment
- Was a participant in the previously conducted focus groups
- If assigned to the online group intervention, unwilling to be audio-recorded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gender-Enhanced -- MasibambaneThe 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. | Behavioural | Masibambane - Gender-Enhanced |
| Individually accessedThe intervention includes an individually-accessed online PrEP video and South African government websites on PrEP and on contraception options | Behavioural | Individually accessed |
Primary outcome
Percent of Participants Who Have an Individual Counseling Session About PrEP.
Time frame: 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
2 secondary outcomes
Percent of Participants Who Undergo HIV-testing and Counseling (HCT).
Time frame: Immediate post-intervention up to 3 months after the intervention
Percent Taking up PrEP
Time frame: Immediate post-intervention up to 3 months after the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35306944Harrison 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.
- Background: PubMed 35218452Bergam 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.
- Background: PubMed 38416275Fordjuoh 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.
- Background: PubMed 36735226Hanass-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.
- Publically-available website about the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gender-Enhanced -- Masibambane and Individually accessed in people with HIV Infections, run by New York State Psychiatric Institute at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants Who Have an Individual Counseling Session About PrEP. (time frame: Immediate post-intervention up to 3 months after the intervention (i.e., as reported on the 3-month follow-up and nurse counselor log)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04833127, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.