Peer-Delivered HIV Self-Testing, STI Self-Sampling and PrEP for Transgender Women in Uganda

NCT04328025 | Unknown DMC

• 1 other identifier: REC REF 0304-2019
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

HIV; Sexually Transmitted Infections; PrEP; Transgender Women

Outcome Measures

Primary Outcomes (3)

• 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

  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

  12 months

• PrEP effectiveness as measured by intracellular tenofovir diphosphate levels in dried blood spots

  Comparison of PrEP effectiveness by randomization arm

  12 months

Secondary Outcomes (3)

• Sexual risk behavior as measured by frequency of self-reported unprotected sex

  12 months

• STI incidence as measured by GeneXpert Chlamydia and Gonorrhoeae PRC testing

  12 months

• PrEP initiation as measured by pharmacy records

  12 months

Study Arms (2)

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).

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.

Interventions

Peer-delivered HIV self-testing, STI self-sampling and PrEP OTHER

Peer delivery of combination HIV prevention interventions to transgender women.

Peer-Delivered HIV Self-Testing, STI Self-Sampling and PrEP

Eligibility Criteria

• Age: 14 Years+
• Gender Eligibility Details: Self-identify as transgender women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Makerere University: lead
• Massachusetts General Hospital: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• University of Washington: collaborator

Study Sites (1)

Infectious Diseases Institute Kasangati

Kampala, Uganda

Location

Related Publications (2)

• 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.

  PMID: 39250646 DERIVED

• Mujugira 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.

  PMID: 34954718 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Mujugira, PhD

  Infectious Diseases Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 31, 2020
• Study Start: October 26, 2020
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)