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Completed

NCT Number: NCT03586128

Partners PrEP Program

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Makerere University

Kampala, Uganda

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

ART

Drug

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

Primary outcomes

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

    Time frame: Up to 24 months

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

  2. HIV viral load suppression of HIV-positive members of a discordant partnership

    Time frame: Up to 24 months

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

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

    Time frame: Up to 24 months

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

  4. PrEP adherence of HIV-negative members of a discordant partnership

    Time frame: 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 outcomes

  1. PrEP-taking as a modeled behavior

    Time frame: 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.

  2. Facilitators and barriers to use of ART and PrEP

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Harvard University
  • Makerere University

Registry information

Official study title

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

Acronym: PPP

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 13, 2018
Registry last updated
Dec 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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