CompletedPhase 4

Partners Demonstration Project of PrEP and ART

Kenya, Uganda1,013 participantsStarted 2012-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

What they're measuring

Ability to recruit high-risk HIV-1 serodiscordant couples: Screen-to-eligible ratio.

Timeframe: 24 months

Ability to recruit high-risk HIV-1 serodiscordant couples: Eligible couples who decide to enroll in the cohort.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: 24 months

PrEP initiation by HIV uninfected partners.

Timeframe: 24 months

PrEP adherence: Self-reported missed doses of PrEP.

Timeframe: 24 months

Trial details

NCT IDNCT02775929

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-06

View on ClinicalTrials.gov More HIV Infection trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Ability to recruit high-risk HIV-1 serodiscordant couples: Screen-to-eligible ratio.

Timeframe: 24 months

Ability to recruit high-risk HIV-1 serodiscordant couples: Eligible couples who decide to enroll in the cohort.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: 24 months

PrEP initiation by HIV uninfected partners.

Timeframe: 24 months

PrEP adherence: Self-reported missed doses of PrEP.

Timeframe: 24 months