PPP: Partners PrEP Program

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT03586128
• Collaborator: Harvard University (Other), Makerere University (Other)
• Enrollment: 1,381
• Location: 1
• Actual Duration (Months): 41.4
• Patients Per Site Per Month: 33.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: PrEP; Drug: ART

Study Design

• Study Type: Observational
• Actual Enrollment: 1381 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Integrated PrEP and ART Delivered in Ugandan Public Health Clinics to Improve HIV and ART Outcomes for HIV Serodiscordant Couples
• Actual Study Start Date: Jun 8, 2018
• Actual Primary Completion Date: Nov 19, 2021
• Actual Study Completion Date: Nov 19, 2021

Arms and Interventions

Arm

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.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Makerere University	Kampala		Uganda

Sponsors and Collaborators

• University of Washington
• Harvard University
• Makerere University

Investigators

• Principal Investigator: Renee Heffron, PhD, MPH, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Renee Heffron, Assistant Professor, School of Public Health: Global Health, University of Washington
• ClinicalTrials.gov Identifier: NCT03586128
• Other Study ID Numbers: STUDY00000320
• First Posted: Jul 13, 2018
• Last Update Posted: Dec 6, 2021
• Last Verified: Dec 1, 2021

• 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
• Additional relevant MeSH terms: HIV Infections

Study Results

No Results Posted as of Dec 6, 2021