Partners PrEP Program

NCT03586128 | Completed DMC FDA Drug

• 1 other identifier: STUDY00000320
• Study Type: observational
• Target: 1,381
• Locations: 1 country
• Sites: 1

Brief Summary

Through close collaboration with the Ugandan Ministry of Health, the investigators plan to provide PrEP for HIV-negative members of HIV serodiscordant couples by launching PrEP delivery within 12 public ART clinics in Kampala, Uganda. Intervention delivery will be launched in a staggered fashion among clinics through a stepped wedge cluster randomized trial providing a rigorous research opportunity to measure the effect of the intervention on PrEP and ART initiation and adherence. To measure these outcomes using clinic records and biomarkers, the program will enroll approximately 1440 HIV serodiscordant couples. Additionally, the program will collect qualitative and quantitative data to determine if PrEP-taking is a modeled behavior that facilitates ART use and characterize the way that PrEP and ART use interact within couples and estimate the programmatic costs of the integrated PrEP and ART strategy.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (4)

• Number of HIV-positive members of a discordant partnership who initiate ART

  Measure ART initiation of the HIV-positive member of the couple

  Up to 24 months

• HIV viral load suppression of HIV-positive members of a discordant partnership

  ART adherence by measuring HIV viral load of the HIV-positive member of the couple

  Up to 24 months

• Number of HIV-negative members of a discordant partnership who initiate PrEP

  Measure PrEP initiation of the HIV-negative member of the couple

  Up to 24 months

• PrEP adherence of HIV-negative members of a discordant partnership

  Measure PrEP adherence, among HIV-negative members of a discordant partnership who initiated PrEP, by self-report and tenofovir drug level testing.

  Up to 24 months

Secondary Outcomes (3)

• PrEP-taking as a modeled behavior

  Up to 24 months

• Facilitators and barriers to use of ART and PrEP

  Up to 24 months

• Programmatic costs of providing integrated PrEP and ART to HIV serodiscordant couples

  Up to 24 months

Study Arms (1)

HIV serodiscordant couples

Drug: PrEP; Drug: ART

Interventions

PrEP DRUG

PrEP will be introduced into clinics according to Uganda national guidelines using a stepped wedge design. Uganda guidelines recommend any tenofovir disoproxil fumarate (TDF) containing medication be used for PrEP; this includes emtricitabine (FTC)/TDF, lamivudine (3TC)/TDF or TDF alone.

HIV serodiscordant couples

ART DRUG

ART medication will be provided according to Uganda national guidelines for persons living with HIV.

HIV serodiscordant couples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV serodiscordant couples from the Kampala, Uganda area

You may qualify if:

• For both members of the couple
• Age ≥18 years
• Able and willing to provide informed consent
• Sexually active with each other
• Willing to engage with the clinic system as a couple
• For HIV-positive members of the couples (index participants)
• HIV-positive, according to national HIV testing algorithm
• Recent diagnosis as a member in an HIV serodiscordant couple
• Not currently enrolled in an HIV treatment clinical trial
• For HIV-negative members of the couples (partner participants)
• HIV-negative, according to national HIV testing algorithm
• Recent diagnosis as a member in an HIV serodiscordant couple
• Not currently enrolled in an HIV treatment clinical trial
• Not currently using PrEP
• Eligible for PrEP, according to WHO or Ugandan national guidelines

Sponsors & Collaborators

• University of Washington: lead
• Harvard University: collaborator
• Makerere University: collaborator

Study Sites (1)

Makerere University

Kampala, Uganda

Location

Related Publications (2)

• Wyatt MA, Pisarski EE, Nalumansi A, Kasiita V, Kamusiime B, Nalukwago GK, Thomas D, Muwonge TR, Mujugira A, Heffron R, Ware NC; Partners PrEP Program Study Team. How PrEP delivery was integrated into public ART clinics in central Uganda: A qualitative analysis of implementation processes. PLOS Glob Public Health. 2024 Mar 7;4(3):e0002916. doi: 10.1371/journal.pgph.0002916. eCollection 2024.

  PMID: 38452111 DERIVED

• Heffron R, Muwonge TR, Thomas KK, Nambi F, Nakabugo L, Kibuuka J, Thomas D, Feutz E, Meisner A, Ware NC, Wyatt MA, Simoni JM, Katz IT, Kadama H, Baeten JM, Mujugira A; Partners PrEP Program Team. PrEP uptake and HIV viral suppression when PrEP is integrated into Ugandan ART clinics for HIV-negative members of HIV-serodifferent couples: A stepped wedge cluster randomized trial. EClinicalMedicine. 2022 Aug 11;52:101611. doi: 10.1016/j.eclinm.2022.101611. eCollection 2022 Oct.

  PMID: 35990584 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Renee Heffron, PhD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Public Health: Global Health

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 13, 2018
• Study Start: June 8, 2018
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: December 6, 2021

Record last verified: 2021-12

Locations

UG (1)