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 range

18 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years

Sex

ALL

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