Partners PrEP Program

Conditions

HIV Infections

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.

Monique A. Wyatt, Emily E. Pisarski, Alisaati Nalumansi, Vicent Kasiita, Brenda Kamusiime et al. (12 authors)

PLOS Global Public Health2024-03-07

10.1371/journal.pgph.0002916

How Central Ugandan HIV Clinics Adapted During COVID-19 Lockdown Restrictions to Promote Continuous Access to Care: A Qualitative Analysis

Norma C. Ware, Monique A. Wyatt, Emily E. Pisarski, Alisaati Nalumansi, Vicent Kasiita et al. (12 authors)

AIDS and Behavior2023-06-026 citations

10.1007/s10461-023-04090-4

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.

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.

2022-08-1114 citations

10.1016/j.eclinm.2022.101611

A pragmatic approach to identifying implementation barriers and facilitators for a novel pre-exposure prophylaxis (PrEP) delivery model at public facilities in urban Uganda

Dorothy Thomas, Andrew Mujugira, Katrina F. Ortblad, Sylvia Namanda, Joseph Kibuuka et al. (11 authors)

Implementation Science Communications2022-01-2817 citations

10.1186/s43058-022-00254-w

Interventions

DRUGPrEP

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.

DRUGART

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Number of HIV-positive members of a discordant partnership who initiate ART	Up to 24 months	Measure ART initiation of the HIV-positive member of the couple
HIV viral load suppression of HIV-positive members of a discordant partnership	Up to 24 months	ART adherence by measuring HIV viral load of the HIV-positive member of the couple
Number of HIV-negative members of a discordant partnership who initiate PrEP	Up to 24 months	Measure PrEP initiation of the HIV-negative member of the couple
PrEP adherence of HIV-negative members of a discordant partnership	Up to 24 months	Measure PrEP adherence, among HIV-negative members of a discordant partnership who initiated PrEP, by self-report and tenofovir drug level testing.

Secondary

Measure	Time frame	Description
Facilitators and barriers to use of ART and PrEP	Up to 24 months	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.
Programmatic costs of providing integrated PrEP and ART to HIV serodiscordant couples	Up to 24 months	Conduct micro-costing, cost-effectiveness, and budget impact analyses to estimate the programmatic costs of providing integrated PrEP and ART to HIV serodiscordant couples.
PrEP-taking as a modeled behavior	Up to 24 months	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.

Countries

Uganda

Outcome results

None listed