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Partners PrEP Program

NCT ID: NCT03586128

Last Updated: 2021-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1381 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-08

Study Completion Date

2021-11-19

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV serodiscordant couples

PrEP

Intervention Type 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

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

ART

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Harvard University

OTHER

Sponsor Role collaborator

Makerere University

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Renee Heffron

Assistant Professor, School of Public Health: Global Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Renee Heffron, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Makerere University

Kampala, , Uganda

Site Status

Countries

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Uganda

References

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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.

Reference Type DERIVED
PMID: 38452111 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35990584 (View on PubMed)

Other Identifiers

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STUDY00000320

Identifier Type: -

Identifier Source: org_study_id