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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
Sponsor:
Collaborators:
Harvard University
Makerere University
Information provided by (Responsible Party):
Renee Heffron, University of Washington

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
HIV Infections Drug: PrEP Drug: ART

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Study Type : Observational
Estimated Enrollment : 1440 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 : June 8, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
HIV serodiscordant couples from the Kampala, Uganda area
Criteria

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


Information from the National Library of Medicine

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


Contacts
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Contact: Renee Heffron, PhD, MPH 206-520-3800 rheffron@uw.edu
Contact: Caitlin Scoville, MPH 206-520-3809 cwscov@uw.edu

Locations
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Uganda
Makerere University Recruiting
Kampala, Uganda
Contact: Elly Katabira, MBChB       katabira@imul.com   
Contact: Andrew Mujugira, MBChB, PhD       mujugira@uw.edu   
Sponsors and Collaborators
University of Washington
Harvard University
Makerere University
Investigators
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Principal Investigator: Renee Heffron, PhD, MPH University of Washington

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Responsible Party: Renee Heffron, Assistant Professor, School of Public Health: Global Health, University of Washington
ClinicalTrials.gov Identifier: NCT03586128     History of Changes
Other Study ID Numbers: STUDY00000320
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

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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:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases