Overview

This trial is active, not recruiting.

Condition hiv infection
Treatments ftc-tdf prep, art
Phase phase 4
Sponsor University of Washington
Collaborator Bill and Melinda Gates Foundation
Start date November 2012
End date June 2016
Trial size 1013 participants
Trial identifier NCT02775929, 42903-IRB-J, R01MH095507

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Other)
FTC-TDF PrEP for HIV uninfected partners and ART for HIV infected partners
ftc-tdf prep
FTC-TDF PrEP for HIV-1 uninfected partners
art
ART for HIV-1 infected partners

Primary Outcomes

Measure
Ability to recruit high-risk HIV-1 serodiscordant couples: Screen-to-eligible ratio.
time frame: 24 months
Ability to recruit high-risk HIV-1 serodiscordant couples: Eligible couples who decide to enroll in the cohort.
time frame: 24 months
Ability to recruit high-risk HIV-1 serodiscordant couples: Costs of screening and targeting high-risk couples decide to enroll in the cohort.
time frame: 24 months
User preferences for ART initiation for HIV-1 infected partners and PrEP for HIV-1 uninfected partners: preferred ART-based HIV prevention method.
time frame: 24 months
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.
time frame: 24 months
PrEP initiation by HIV uninfected partners.
time frame: 24 months
PrEP adherence: Self-reported missed doses of PrEP.
time frame: 24 months
PrEP adherence: Detectable and quantifiable PrEP levels in plasma.
time frame: 24 months
PrEP adherence: PrEP hold.
time frame: 24 months
ART initiation.
time frame: 24 months
ART Adherence.
time frame: 24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Sexual frequency.
time frame: 24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Condom use frequency.
time frame: 24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Outside partners for HIV-1 uninfected partners.
time frame: 24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Gender of the HIV-1 uninfected partner.
time frame: 24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Fertility intentions.
time frame: 24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Relationship dissolution.
time frame: 24 months
Correlates of preferences, uptake, and adherence to ART and PrEP: Depression and substance use.
time frame: 24 months
Correlates of preferences, uptake and adherence to ART and PrEP: ART initiation by HIV-1 infected partner.
time frame: 24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Number of children.
time frame: 24 months
Correlates of preferences, uptake and adherence to ART and PrEP: CD4 count.
time frame: 24 months
Correlates of preferences, uptake and adherence to ART and PrEP: WHO stage of HIV-1 infected partner.
time frame: 24 months
Feasibility to PrEP discontinuation in couples when the HIV-1 infected partner initiates ART.
time frame: 24 months
PrEP use and pregnancy: HIV-1 infection.
time frame: 24 months
PrEP use and pregnancy: Congenital abnormalities among infants born to female Participants taking PrEP.
time frame: 24 months
PrEP use and pregnancy: Any serious adverse event.
time frame: 24 months
Infant growth for women who continue PrEP in pregnancy: Length.
time frame: 24 months
Infant growth for women who continue PrEP in pregnancy: Weight.
time frame: 24 months
Infant growth for women who continue PrEP in pregnancy: Head circumference.
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title An Open Label, Pilot Demonstration and Evaluation Project of Antiretroviral-based HIV-1 Prevention Among High-risk Serodiscordant African Couples
Principal investigator Jared M Baeten, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Washington.