HIVNCT04328025
Peer-Delivered HIV Self-Testing, STI Self-Sampling and PrEP for Transgender Women in Uganda
A study testing Peer-delivered HIV self-testing, STI self-sampling and PrEP in people with HIV and Sexually Transmitted Infections, run by Makerere University at 1 site in Uganda.
Trial summary
Transgender women (TGW) are at high risk for HIV infection, and are an important, under-researched population in sub-Saharan Africa. Globally, HIV acquisition risk among TGW is 13 times higher than other adults aged 15-49 years. In Uganda, HIV prevalence among TGW is 22% compared to 5.9% in the general population. Read more about this study
- Who is it for?
- Ages 14 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Sexually Transmitted Infections, PrEP
- What is being tested?
- Peer-delivered HIV self-testing, STI self-sampling and PrEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUganda
- Study dates
- 26 Oct 2020to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 years and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Report male sex assigned at birth
- Age ≥18
- If 14-17 years, qualification as a mature or emancipated minor due to having a sexually transmitted infection or cater for own livelihood
- Report condom-less anal intercourse in the past 6 months
- Able and willing to provide written informed consent
- Possess a valid recruitment coupon
Show all 9Show fewer
- HIV-uninfected based on negative HIV rapid tests at the enrollment visit
- Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance ≥60 mL/min
- Not infected with hepatitis B virus, as determined by a negative hepatitis B surface antigen test
Who cannot join
- Currently enrolled in a biomedical HIV prevention study
- Any clinically significant or chronic medical condition that is considered progressive or in the opinion of the investigator would make the participant unsuitable for the study, including severe infections requiring treatment such as tuberculosis, alcohol or drug abuse, or mental illness which precludes provision of informed consent
- Not planning to remain in the geographic area for the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Transgender women (TGW) are at high risk for HIV infection, and are an important, under-researched population in sub-Saharan Africa. Globally, HIV acquisition risk among TGW is 13 times higher than other adults aged 15-49 years. In Uganda, HIV prevalence among TGW is 22% compared to 5.9% in the general population. Encouraging use of self-controlled HIV prevention tools - specifically, HIV self-testing (HIVST), STI self-sampling (STISS) and antiretroviral pre-exposure prophylaxis (PrEP) - to those testing HIV negative could decrease HIV incidence among African TGW. This R34 application proposes formative research and a pilot trial to develop an HIV prevention intervention for African transgender women (TGW). The investigators will evaluate whether peer-delivered combination HIV prevention increases testing uptake and empowers effective prevention decision making in TGW. Peer-led interventions are effective in increasing HIV and STI testing among other hard-to-reach vulnerable populations with high HIV prevalence but low testing coverage and are recommended by the World Health Organization. Exploring peer-delivery approaches to increase coverage of combination HIV prevention interventions is key to addressing research gaps in HIV epidemic control. However, little is known about the effectiveness of peer-delivered combination HIV prevention (HIVST, STISS and PrEP) for African TGW, or the best way to deliver care to this population. Key knowledge gaps include: 1) whether peer delivery increases testing rates and status knowledge, 2) the role of peers in creating demand for repeat testing and PrEP, and 3) how to optimize peer delivery of combination HIV prevention (HIVST, STISS and PrEP). To address these questions, this proposal seeks to conduct formative research to inform implementation of peer-delivered combination HIV prevention for African TGW (Aim 1), implement a pilot cluster randomized trial to evaluate the feasibility, acceptability and preliminary effectiveness of peer delivered combination HIV prevention (Aim 2), and conduct in-depth interviews to explore how peer-delivery of HIVST, STISS and PrEP influences prevention choices among TGW and sexual partners (Aim 3). This will be the first clinical trial, to our knowledge, to evaluate HIV self-testing and STI self-sampling in HIV-uninfected TGW. Pilot data from TGW and their partners will provide unique perspectives to inform HIV prevention delivery. The proposed proof-of-concept evaluation is uniquely positioned to improve prevention uptake for African TGW - a high-risk, marginalized, and underserved population. Rigorous application of mixed methodologies will generate actionable data for policy and programs, and provide a strong foundation for scalable implementation of cutting edge combination HIV prevention interventions for African TGW. The local transgender community is involved in study design, planning and implementation. This project is supported by the Ugandan Ministry of Health.
Read the detailed description
Transgender women (TGW) are at high risk for HIV infection, and are an important, under-researched population in sub-Saharan Africa. Globally, HIV acquisition risk among TGW is 13 times higher than other adults aged 15-49 years. In Uganda, HIV prevalence among TGW is 22% compared to 5.9% in the general population. Encouraging use of self-controlled HIV prevention tools - specifically, HIV self-testing (HIVST), STI self-sampling (STISS) and antiretroviral pre-exposure prophylaxis (PrEP) - among those testing HIV negative could decrease HIV incidence among African TGW and secondary transmission to their sexual partners. This study comprises formative research and a pilot trial to develop an HIV prevention intervention for African TGW. The investigators will evaluate whether peer-delivered combination HIV prevention increases testing uptake and empowers effective prevention decision making in TGW. Peer-led interventions are effective in increasing HIV and STI testing among other hard-to-reach vulnerable populations with high HIV prevalence but low testing coverage and are recommended by the World Health Organization (WHO). Exploring peer-delivery approaches to increase coverage of combination HIV prevention interventions is key to addressing research gaps in HIV epidemic control. However, little is known about the effectiveness of peer-delivered combination HIV prevention (HIVST, STISS and PrEP) for African TGW, or the best way to deliver care to this population. Key knowledge gaps include: 1) whether peer delivery increases testing rates and status knowledge, 2) the role of peers in creating demand for repeat testing and PrEP, and 3) how to optimize peer delivery of combination HIV prevention (HIVST, STISS and PrEP).
To address these questions, this protocol describes formative research to inform implementation of peer-delivered combination HIV prevention for African TGW, followed by implementation of a pilot cluster randomized trial to evaluate the feasibility, acceptability and preliminary effectiveness of peer delivered combination HIV prevention, and in-depth interviews to explore how peer-delivery of HIVST, STISS and PrEP influences prevention choices among TGW and sexual partners. This will be the first clinical trial, to our knowledge, to evaluate HIV self-testing and STI self-sampling in HIV-uninfected TGW.
Aim 1: Conduct formative research to inform implementation of peer-delivered combination HIV prevention for African TGW.
Approach: Using the Social Ecological framework, the investigators will conduct in-depth interviews with TG peers, healthcare providers, civil society members, and Ministry of Health officials to: a) explore barriers and likely facilitators of HIVST, STISS and PrEP; and b) assess feasibility of respondent-driven sampling (RDS), the recruitment strategy for Aim 2.
Hypothesis: Respondents will provide insights into the feasibility and acceptability of peer-delivered HIVST, STISS and PrEP, and RDS recruitment.
Aim 2: Evaluate the feasibility, acceptability and preliminary effectiveness of peer-delivered combination HIV prevention (HIVST, STISS and PrEP) for African TGW by implementing a pilot cluster randomized controlled trial.
Approach: To pilot-test the effectiveness of this peer-delivered combination HIV prevention intervention, 10 TGW peer groups (1 peer and 8 participants) will be randomized in a 1:1 ratio to either monthly peer delivery of HIVST, STISS and PrEP (intervention arm) or quarterly in-clinic HIV testing and PrEP prescription (control arm). All will enroll at clinic and initiate PrEP. In between quarterly clinic visits, trained peers will: a) deliver additional HIVST kits and PrEP refills; b) distribute STI self-sampling kits to TGW for own use and with regular partners; and c) use smart phone instructional videos showing TGW how to self-collect pharyngeal, rectal \& urine specimens. The investigators will provide: i) free testing and treatment of Neisseria gonorrhoeae and Chlamydia trachomatis; and ii) peer-assisted partner notification services. Primary outcomes are intervention feasibility, acceptability \& PrEP adherence.
Hypothesis: Peer delivery will be feasible and acceptable, with higher uptake of testing and PrEP compared with control arm.
Aim 3: Explore how peer-delivery of HIVST, STISS and PrEP influences prevention choices among TGW and sexual partners.
Approach: To clarify the process through which peer-delivery may influence prevention choices, the investigators will conduct in-depth interviews with participants and their partners to assess perceptions and experiences with peer-delivered HIV/STI services, status disclosure, partner notification, behavior change and PrEP use.
Hypothesis: Peer-delivered combination HIV prevention will empower TGW to engage in prevention services, facilitate partner testing and efficiently identify persons with undiagnosed HIV and/or STIs.
- Conditions
- HIV, Sexually Transmitted Infections, PrEP, Transgender Women
- Being tested
- Peer-delivered HIV self-testing, STI self-sampling and PrEP
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-delivered HIV self-testing, STI self-sampling and PrEPOther
Peer delivery of combination HIV prevention interventions to transgender women.
| Study group | Role | What they receive |
|---|---|---|
| Peer-Delivered HIV Self-Testing, STI Self-Sampling and PrEP | Active comparator | For TGW in the intervention arm, peers will deliver HIVST and PrEP medications monthly in between quarterly clinic visits. Quarterly clinic-based testing will confirm accuracy of self-tests and identify inaccurate test results. Additionally, peers will remind TGW to self-test before opening a new PrEP bottle. They will also distribute STI self-sampling kits to TGW for own use, and with regular partners as needed. They will present smart phone instructional videos showing trans women how to self-collect pharyngeal, rectal and urine specimens for Neisseria gonorrhoeae and Chlamydia trachomatis testing.
Peers will: a) motivate ongoing adherence; b) promote repeat HIV testing; and c) support PrEP use as problems arise. Self-sampling for STIs will be performed monthly by participants (with questions answered by the peer or other study staff as needed). Receives: Other: Peer-delivered HIV self-testing, STI self-sampling and PrEP |
| Facility-Delivered Care | No intervention | Participants will receive facility-based HIV counseling, PrEP prescriptions condoms, risk reduction counseling, and management of sexually transmitted infections as standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of peer-delivered prevention as measured by number of HIV and STI self-test kits delivered to intervention arm participants
Proportion of kits successfully delivered
Measured: 12 months
Acceptability of peer-delivered prevention as measured by 5-point Likert scales and qualitative interviews
Proportion of intervention arm participants using HIV/STI self-test kits
Measured: 12 months
PrEP effectiveness as measured by intracellular tenofovir diphosphate levels in dried blood spots
Comparison of PrEP effectiveness by randomization arm
Measured: 12 months
Secondary outcomes (3)
Sexual risk behavior as measured by frequency of self-reported unprotected sex
Comparison of unprotected sexual frequency by randomization arm
Measured: 12 months
STI incidence as measured by GeneXpert Chlamydia and Gonorrhoeae PRC testing
Comparison of STI incidence by randomization arm
Measured: 12 months
PrEP initiation as measured by pharmacy records
Proportion of participants initiating PrEP
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start26 Oct 2020
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization in a 1:1 ratio to either monthly peer delivery of HIV self-testing, STI self-sampling and PrEP (intervention arm) or quarterly in-clinic HIV testing and PrEP prescription (control arm)
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Harvard Medical School (HMS and HSDM), University of Washington
- Responsible party
- Sponsor
- Investigators
- Andrew Mujugira, PhD, Principal investigator, Infectious Diseases Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328025
- Sponsor's protocol ID
- REC REF 0304-2019
- Status last verified
- Apr 2021
- First submitted
- 20 Mar 2020
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mujugira A, Karungi B, Nakyanzi A, Bagaya M, Nsubuga R, Sebuliba T, Nampewo O, Naddunga F, Birungi JE, Sapiri O, Nyanzi KR, Bambia F, Muwonge T, Gandhi M, Haberer JE. Peer-Delivered HIV Self-Testing, Sexually Transmitted Infection Self-Sampling, and Pre-exposure Prophylaxis for Transgender Women in Uganda: A Randomized Trial. J Acquir Immune Defic Syndr. 2024 Oct 1;97(2):125-132. doi: 10.1097/QAI.0000000000003471.
PubMed 39250646Mujugira A, Nakyanzi A, Nabaggala MS, Muwonge TR, Ssebuliba T, Bagaya M, Nampewo O, Sapiri O, Nyanzi KR, Bambia F, Nsubuga R, Serwadda DM, Ware NC, Baeten JM, Haberer JE. Effect of HIV Self-Testing on PrEP Adherence Among Gender-Diverse Sex Workers in Uganda: A Randomized Trial. J Acquir Immune Defic Syndr. 2022 Apr 1;89(4):381-389. doi: 10.1097/QAI.0000000000002895.
PubMed 34954718
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-Delivered HIV Self-Testing, STI Self-Sampling and PrEP for Transgender Women in Uganda
- ClinicalTrials.gov ID
- NCT04328025
- Acronym / sponsor ID
- REC REF 0304-2019
- Conditions
- HIV, Sexually Transmitted Infections, PrEP, Transgender Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Harvard Medical School (HMS and HSDM), University of Washington
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transgender women (TGW) are at high risk for HIV infection, and are an important, under-researched population in sub-Saharan Africa. Globally, HIV acquisition risk among TGW is 13 times higher than other adults aged 15-49 years. In Uganda, HIV prevalence among TGW is 22% compared to 5.9% in the general population. Encouraging use of self-controlled HIV prevention tools - specifically, HIV self-testing (HIVST), STI self-sampling (STISS) and antiretroviral pre-exposure prophylaxis (PrEP) - to those testing HIV negative could decrease HIV incidence among African TGW. This R34 application proposes formative research and a pilot trial to develop an HIV prevention intervention for African transgender women (TGW). The investigators will evaluate whether peer-delivered combination HIV prevention increases testing uptake and empowers effective prevention decision making in TGW. Peer-led interventions are effective in increasing HIV and STI testing among other hard-to-reach vulnerable populations with high HIV prevalence but low testing coverage and are recommended by the World Health Organization. Exploring peer-delivery approaches to increase coverage of combination HIV prevention interventions is key to addressing research gaps in HIV epidemic control. However, little is known about the effectiveness of peer-delivered combination HIV prevention (HIVST, STISS and PrEP) for African TGW, or the best way to deliver care to this population. Key knowledge gaps include: 1) whether peer delivery increases testing rates and status knowledge, 2) the role of peers in creating demand for repeat testing and PrEP, and 3) how to optimize peer delivery of combination HIV prevention (HIVST, STISS and PrEP). To address these questions, this proposal seeks to conduct formative research to inform implementation of peer-delivered combination HIV prevention for African TGW (Aim 1), implement a pilot cluster randomized trial to evaluate the feasibility, acceptability and preliminary effectiveness of peer delivered combination HIV prevention (Aim 2), and conduct in-depth interviews to explore how peer-delivery of HIVST, STISS and PrEP influences prevention choices among TGW and sexual partners (Aim 3). This will be the first clinical trial, to our knowledge, to evaluate HIV self-testing and STI self-sampling in HIV-uninfected TGW. Pilot data from TGW and their partners will provide unique perspectives to inform HIV prevention delivery. The proposed proof-of-concept evaluation is uniquely positioned to improve prevention uptake for African TGW - a high-risk, marginalized, and underserved population. Rigorous application of mixed methodologies will generate actionable data for policy and programs, and provide a strong foundation for scalable implementation of cutting edge combination HIV prevention interventions for African TGW. The local transgender community is involved in study design, planning and implementation. This project is supported by the Ugandan Ministry of Health.
Detailed description
Transgender women (TGW) are at high risk for HIV infection, and are an important, under-researched population in sub-Saharan Africa. Globally, HIV acquisition risk among TGW is 13 times higher than other adults aged 15-49 years. In Uganda, HIV prevalence among TGW is 22% compared to 5.9% in the general population. Encouraging use of self-controlled HIV prevention tools - specifically, HIV self-testing (HIVST), STI self-sampling (STISS) and antiretroviral pre-exposure prophylaxis (PrEP) - among those testing HIV negative could decrease HIV incidence among African TGW and secondary transmission to their sexual partners. This study comprises formative research and a pilot trial to develop an HIV prevention intervention for African TGW. The investigators will evaluate whether peer-delivered combination HIV prevention increases testing uptake and empowers effective prevention decision making in TGW. Peer-led interventions are effective in increasing HIV and STI testing among other hard-to-reach vulnerable populations with high HIV prevalence but low testing coverage and are recommended by the World Health Organization (WHO). Exploring peer-delivery approaches to increase coverage of combination HIV prevention interventions is key to addressing research gaps in HIV epidemic control. However, little is known about the effectiveness of peer-delivered combination HIV prevention (HIVST, STISS and PrEP) for African TGW, or the best way to deliver care to this population. Key knowledge gaps include: 1) whether peer delivery increases testing rates and status knowledge, 2) the role of peers in creating demand for repeat testing and PrEP, and 3) how to optimize peer delivery of combination HIV prevention (HIVST, STISS and PrEP).
To address these questions, this protocol describes formative research to inform implementation of peer-delivered combination HIV prevention for African TGW, followed by implementation of a pilot cluster randomized trial to evaluate the feasibility, acceptability and preliminary effectiveness of peer delivered combination HIV prevention, and in-depth interviews to explore how peer-delivery of HIVST, STISS and PrEP influences prevention choices among TGW and sexual partners. This will be the first clinical trial, to our knowledge, to evaluate HIV self-testing and STI self-sampling in HIV-uninfected TGW.
Aim 1: Conduct formative research to inform implementation of peer-delivered combination HIV prevention for African TGW.
Approach: Using the Social Ecological framework, the investigators will conduct in-depth interviews with TG peers, healthcare providers, civil society members, and Ministry of Health officials to: a) explore barriers and likely facilitators of HIVST, STISS and PrEP; and b) assess feasibility of respondent-driven sampling (RDS), the recruitment strategy for Aim 2.
Hypothesis: Respondents will provide insights into the feasibility and acceptability of peer-delivered HIVST, STISS and PrEP, and RDS recruitment.
Aim 2: Evaluate the feasibility, acceptability and preliminary effectiveness of peer-delivered combination HIV prevention (HIVST, STISS and PrEP) for African TGW by implementing a pilot cluster randomized controlled trial.
Approach: To pilot-test the effectiveness of this peer-delivered combination HIV prevention intervention, 10 TGW peer groups (1 peer and 8 participants) will be randomized in a 1:1 ratio to either monthly peer delivery of HIVST, STISS and PrEP (intervention arm) or quarterly in-clinic HIV testing and PrEP prescription (control arm). All will enroll at clinic and initiate PrEP. In between quarterly clinic visits, trained peers will: a) deliver additional HIVST kits and PrEP refills; b) distribute STI self-sampling kits to TGW for own use and with regular partners; and c) use smart phone instructional videos showing TGW how to self-collect pharyngeal, rectal \& urine specimens. The investigators will provide: i) free testing and treatment of Neisseria gonorrhoeae and Chlamydia trachomatis; and ii) peer-assisted partner notification services. Primary outcomes are intervention feasibility, acceptability \& PrEP adherence.
Hypothesis: Peer delivery will be feasible and acceptable, with higher uptake of testing and PrEP compared with control arm.
Aim 3: Explore how peer-delivery of HIVST, STISS and PrEP influences prevention choices among TGW and sexual partners.
Approach: To clarify the process through which peer-delivery may influence prevention choices, the investigators will conduct in-depth interviews with participants and their partners to assess perceptions and experiences with peer-delivered HIV/STI services, status disclosure, partner notification, behavior change and PrEP use.
Hypothesis: Peer-delivered combination HIV prevention will empower TGW to engage in prevention services, facilitate partner testing and efficiently identify persons with undiagnosed HIV and/or STIs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization in a 1:1 ratio to either monthly peer delivery of HIV self-testing, STI self-sampling and PrEP (intervention arm) or quarterly in-clinic HIV testing and PrEP prescription (control arm)
| Arm | Type | Receives |
|---|---|---|
| Peer-Delivered HIV Self-Testing, STI Self-Sampling and PrEP | Active comparator | Other: Peer-delivered HIV self-testing, STI self-sampling and PrEPFor TGW in the intervention arm, peers will deliver HIVST and PrEP medications monthly in between quarterly clinic visits. Quarterly clinic-based testing will confirm accuracy of self-tests and identify inaccurate test results. Additionally, peers will remind TGW to self-test before opening a new PrEP bottle. They will also distribute STI self-sampling kits to TGW for own use, and with regular partners as needed. They will present smart phone instructional videos showing trans women how to self-collect pharyngeal, rectal and urine specimens for Neisseria gonorrhoeae and Chlamydia trachomatis testing. Peers will: a) motivate ongoing adherence; b) promote repeat HIV testing; and c) support PrEP use as problems arise. Self-sampling for STIs will be performed monthly by participants (with questions answered by the peer or other study staff as needed). |
| Facility-Delivered Care | No intervention | –Participants will receive facility-based HIV counseling, PrEP prescriptions condoms, risk reduction counseling, and management of sexually transmitted infections as standard of care. |
Who may qualify
- Ages
- 14 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Report male sex assigned at birth
- Age ≥18
- If 14-17 years, qualification as a mature or emancipated minor due to having a sexually transmitted infection or cater for own livelihood
- Report condom-less anal intercourse in the past 6 months
- Able and willing to provide written informed consent
Key exclusion criteria (3 listed)
- Currently enrolled in a biomedical HIV prevention study
- Any clinically significant or chronic medical condition that is considered progressive or in the opinion of the investigator would make the participant unsuitable for the study, including severe infections requiring treatment such as tuberculosis, alcohol or drug abuse, or mental illness which precludes provision of informed consent
- Not planning to remain in the geographic area for the duration of the study
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 |
|---|---|---|
| Peer-delivered HIV self-testing, STI self-sampling and PrEPPeer delivery of combination HIV prevention interventions to transgender women. | Other | Peer-Delivered HIV Self-Testing, STI Self-Sampling and PrEP |
Primary outcome
Feasibility of peer-delivered prevention as measured by number of HIV and STI self-test kits delivered to intervention arm participants
Time frame: 12 months
Proportion of kits successfully delivered
Acceptability of peer-delivered prevention as measured by 5-point Likert scales and qualitative interviews
Time frame: 12 months
Proportion of intervention arm participants using HIV/STI self-test kits
PrEP effectiveness as measured by intracellular tenofovir diphosphate levels in dried blood spots
Time frame: 12 months
Comparison of PrEP effectiveness by randomization arm
3 secondary outcomes
Sexual risk behavior as measured by frequency of self-reported unprotected sex
Time frame: 12 months
STI incidence as measured by GeneXpert Chlamydia and Gonorrhoeae PRC testing
Time frame: 12 months
PrEP initiation as measured by pharmacy records
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Derived from this study: PubMed 39250646Mujugira A, Karungi B, Nakyanzi A, Bagaya M, Nsubuga R, Sebuliba T, Nampewo O, Naddunga F, Birungi JE, Sapiri O, Nyanzi KR, Bambia F, Muwonge T, Gandhi M, Haberer JE. Peer-Delivered HIV Self-Testing, Sexually Transmitted Infection Self-Sampling, and Pre-exposure Prophylaxis for Transgender Women in Uganda: A Randomized Trial. J Acquir Immune Defic Syndr. 2024 Oct 1;97(2):125-132. doi: 10.1097/QAI.0000000000003471.
- Derived from this study: PubMed 34954718Mujugira A, Nakyanzi A, Nabaggala MS, Muwonge TR, Ssebuliba T, Bagaya M, Nampewo O, Sapiri O, Nyanzi KR, Bambia F, Nsubuga R, Serwadda DM, Ware NC, Baeten JM, Haberer JE. Effect of HIV Self-Testing on PrEP Adherence Among Gender-Diverse Sex Workers in Uganda: A Randomized Trial. J Acquir Immune Defic Syndr. 2022 Apr 1;89(4):381-389. doi: 10.1097/QAI.0000000000002895.
- 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.
Andrew Mujugira, PhD principal investigator
Infectious Diseases Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-delivered HIV self-testing, STI self-sampling and PrEP in people with HIV and Sexually Transmitted Infections, run by Makerere University at 1 site in Uganda.
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 9 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: status not confirmed, as of the sponsor's last update on 3 May 2021. 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 Uganda. 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.
Are results available for this study?
Results are not available in the source record.
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?
Feasibility of peer-delivered prevention as measured by number of HIV and STI self-test kits delivered to intervention arm participants (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT04328025, which also lists 2 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 3 May 2021.