Clinical trial NCT03586128: Partners PrEP Program
Official title: Integrated PrEP and ART Delivered in Ugandan Public Health Clinics to Improve HIV and ART Outcomes for HIV Serodiscordant Couples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Harvard University
name: Makerere University
First posted: 2018-07-13
Enrollment: 1381
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV serodiscordant couples from the Kampala, Uganda area

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.


Eligibility 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

Primary outcomes:
measure: Number of HIV-positive members of a discordant partnership who initiate ART
timeFrame: Up to 24 months
measure: HIV viral load suppression of HIV-positive members of a discordant partnership
timeFrame: Up to 24 months
measure: Number of HIV-negative members of a discordant partnership who initiate PrEP
timeFrame: Up to 24 months
measure: PrEP adherence of HIV-negative members of a discordant partnership
timeFrame: Up to 24 months
Secondary outcomes:
measure: PrEP-taking as a modeled behavior
timeFrame: Up to 24 months
measure: Facilitators and barriers to use of ART and PrEP
timeFrame: Up to 24 months
measure: Programmatic costs of providing integrated PrEP and ART to HIV serodiscordant couples
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Makerere University
Study officials:
affiliation: University of Washington
name: Renee Heffron, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.