Clinical trial NCT02775929: Partners Demonstration Project of PrEP and ART
Official title: An Open Label, Pilot Demonstration and Evaluation Project of Antiretroviral-based HIV-1 Prevention Among High-risk Serodiscordant African Couples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infection
Keywords: Tenofovir disoproxil
Emtricitabine
Pre-exposure Prophylaxis
Antiretroviral Therapy
HIV Prevention
FTC TDF
PrEP
HIV Infected Partners
HIV Uninfected Partners
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: National Institute of Mental Health (NIMH)
name: United States Agency for International Development (USAID)
First posted: 2016-05-18
Enrollment: 1013
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this protocol is to determine user preferences for antiretroviral therapy (ART) for HIV-1 infected partners and pre-exposure prophylaxis (PrEP) HIV-1 un-infected partners and to optimize targeted delivery and sustained use of these interventions.

Detailed description: An open-label, prospective cohort study of higher-risk HIV-1 serodiscordant couples in order to determine barriers and facilitators to uptake and sustained adherence to ART for HIV-1 infected partners and daily oral PrEP for HIV-1 uninfected partners. The investigators developed a risk score tool to identify couples at highest risk for HIV-1 transmission. PrEP was offered as a 'bridge' to ART in the partnership - i.e., until ART initiation by the HIV-infected partner and for the first 6 months after ART is started; ART was recommended following national ART guidelines. A subset (up to 80 couples per site) was invited to participate in qualitative in-depth interview and focus group discussions.

Eligibility criteria: Inclusion Criteria:

For couples

* Risk score defining higher HIV-1 risk (≥6)
* Sexually active (defined as having had vaginal intercourse at least 6 times in the previous three months)
* Willing to enter the study as a couple and intending to remain as a couple for the next 12 months
* Did not participate in the Partners PrEP Study

For HIV-1 uninfected members of the couple (partner participants)

* Age ≥18
* Able and willing to provide written informed consent
* HIV-1 uninfected based on negative HIV-1 rapid tests, both at study screening and at the enrollment visit
* Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance \>60 mL/min
* Not infected with hepatitis B virus, as determined by a negative hepatitis B surface antigen test
* Not currently pregnant or breastfeeding
* Not currently enrolled in an HIV-1 prevention clinical trial
* Not currently using PrEP
* Enrollment of individuals with active and serious infections or active clinically significant medical problems will be at the discretion of the site investigator

For HIV-1 infected members of the couple (index participants)

* Age ≥18
* Able and willing to provide written informed consent
* HIV-1 infected based on positive rapid HIV-1 tests, according to national algorithm
* No history of WHO stage III or IV conditions
* Not currently using ART
* Not currently enrolled in an HIV-1 treatment study
* Note: current pregnancy and breastfeeding are permitted for HIV-1 infected partners

Exclusion Criteria:

* Otherwise not eligible based on the above inclusion criteria

Primary outcomes:
measure: Ability to recruit high-risk HIV-1 serodiscordant couples: Screen-to-eligible ratio.
timeFrame: 24 months
measure: Ability to recruit high-risk HIV-1 serodiscordant couples: Eligible couples who decide to enroll in the cohort.
timeFrame: 24 months
measure: Ability to recruit high-risk HIV-1 serodiscordant couples: Costs of screening and targeting high-risk couples decide to enroll in the cohort.
timeFrame: 24 months
measure: User preferences for ART initiation for HIV-1 infected partners and PrEP for HIV-1 uninfected partners: preferred ART-based HIV prevention method.
timeFrame: 24 months
measure: User preferences for ART initiation for HIV-1 infected partners and PrEP for HIV-1 uninfected partners: reasons for choice and concerns about both methods.
timeFrame: 24 months
measure: PrEP initiation by HIV uninfected partners.
timeFrame: 24 months
measure: PrEP adherence: Self-reported missed doses of PrEP.
timeFrame: 24 months
measure: PrEP adherence: Detectable and quantifiable PrEP levels in plasma.
timeFrame: 24 months
measure: PrEP adherence: PrEP hold.
timeFrame: 24 months
measure: ART initiation.
timeFrame: 24 months
measure: ART Adherence.
timeFrame: 24 months
measure: Correlates of preferences, uptake and adherence to ART and PrEP: Sexual frequency.
timeFrame: 24 months
measure: Correlates of preferences, uptake and adherence to ART and PrEP: Condom use frequency.
timeFrame: 24 months
measure: Correlates of preferences, uptake and adherence to ART and PrEP: Outside partners for HIV-1 uninfected partners.
timeFrame: 24 months
measure: Correlates of preferences, uptake and adherence to ART and PrEP: Gender of the HIV-1 uninfected partner.
timeFrame: 24 months
measure: Correlates of preferences, uptake and adherence to ART and PrEP: Fertility intentions.
timeFrame: 24 months
measure: Correlates of preferences, uptake and adherence to ART and PrEP: Relationship dissolution.
timeFrame: 24 months
measure: Correlates of preferences, uptake, and adherence to ART and PrEP: Depression and substance use.
timeFrame: 24 months
measure: Correlates of preferences, uptake and adherence to ART and PrEP: ART initiation by HIV-1 infected partner.
timeFrame: 24 months
measure: Correlates of preferences, uptake and adherence to ART and PrEP: Number of children.
timeFrame: 24 months
measure: Correlates of preferences, uptake and adherence to ART and PrEP: CD4 count.
timeFrame: 24 months
measure: Correlates of preferences, uptake and adherence to ART and PrEP: WHO stage of HIV-1 infected partner.
timeFrame: 24 months
measure: Feasibility to PrEP discontinuation in couples when the HIV-1 infected partner initiates ART.
timeFrame: 24 months
measure: PrEP use and pregnancy: HIV-1 infection.
timeFrame: 24 months
measure: PrEP use and pregnancy: Congenital abnormalities among infants born to female Participants taking PrEP.
timeFrame: 24 months
measure: PrEP use and pregnancy: Any serious adverse event.
timeFrame: 24 months
measure: Infant growth for women who continue PrEP in pregnancy: Length.
timeFrame: 24 months
measure: Infant growth for women who continue PrEP in pregnancy: Weight.
timeFrame: 24 months
measure: Infant growth for women who continue PrEP in pregnancy: Head circumference.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kemri-Ucsf
city: Thika
country: Kenya
facility: Partners in Prevention-Thika
city: Bushenyi
country: Uganda
facility: Kabwohe Clinical Research Center
city: Kampala
country: Uganda
facility: Partners in Prevention-Infectious Diseases Institute LTD
Study officials:
affiliation: University of Washington
name: Jared M Baeten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nakku-Joloba E, Pisarski EE, Wyatt MA, Muwonge TR, Asiimwe S, Celum CL, Baeten JM, Katabira ET, Ware NC. Beyond HIV prevention: everyday life priorities and demand for PrEP among Ugandan HIV serodiscordant couples. J Int AIDS Soc. 2019 Jan;22(1):e25225. doi: 10.1002/jia2.25225.