Partners PrEP Program (PPP)
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|ClinicalTrials.gov Identifier: NCT03586128|
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
|Condition or disease||Intervention/treatment|
|HIV Infections||Drug: PrEP Drug: ART|
|Study Type :||Observational|
|Estimated Enrollment :||1440 participants|
|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 :||June 8, 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2020|
|HIV serodiscordant couples||
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 medication will be provided according to Uganda national guidelines for persons living with HIV.
- 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
- 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
- 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
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586128
|Contact: Renee Heffron, PhD, MPHfirstname.lastname@example.org|
|Contact: Caitlin Scoville, MPHemail@example.com|
|Contact: Elly Katabira, MBChB firstname.lastname@example.org|
|Contact: Andrew Mujugira, MBChB, PhD email@example.com|
|Principal Investigator:||Renee Heffron, PhD, MPH||University of Washington|