Partners PrEP Program (PPP)

Integrated PrEP and ART Delivered in Ugandan Public Health Clinics to Improve HIV and ART Outcomes for HIV Serodiscordant Couples

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: PrEP; Drug: ART

• Study Type: Observational
• Enrollment (Actual): 1381

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • Makerere University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV serodiscordant couples from the Kampala, Uganda area

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Otherwise not eligible based on the above inclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

HIV serodiscordant couples

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP-taking as a modeled behavior	Measure the degree to which PrEP-taking behavior is modeled by HIV-negative partners and the degree to which it is witnessed by HIV-positive partners using questionnaires developed for this purpose.	Up to 24 months
Facilitators and barriers to use of ART and PrEP	Mixed methods assessment of how integrated PrEP and ART is 1) used among couples and 2) implemented by health care providers using qualitative interviews and questionnaires. These data will be aggregated to understand the 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	Conduct micro-costing, cost-effectiveness, and budget impact analyses to estimate the programmatic costs of providing integrated PrEP and ART to HIV serodiscordant couples.	Up to 24 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Harvard University; Makerere University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 8, 2018
• Primary Completion (ACTUAL): November 19, 2021
• Study Completion (ACTUAL): November 19, 2021

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (ACTUAL): July 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 6, 2021
• Last Update Submitted That Met QC Criteria: December 3, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: STUDY00000320

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No