- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03098693
Dyadic-Based Diagnosis, Care, and Prevention for HIV Discordant Couples in Tanzania (DDCP)
Study Overview
Status
Conditions
Detailed Description
The investigators propose to conduct a prospective observational study of cohabitating couples aged 18 years and above in Kisarawe, Tanzania who will be provided: (1) distribution of HIV self-testing kits to cohabitating couples; (2) linkage to confirmatory HIV-testing & counseling for those who test HIV-positive; (3) facilitated enrollment to care and treatment for those couples with confirmed HIV infection; and (4) for HIV serodiscordant couples, access to PrEP for the HIV-negative partner. A baseline survey, and a follow-up survey approximately 2 weeks later and HIV test, will be administered to all couples involved in the self-testing phase of the study. A cohort of 60 to 70 HIV serodiscordant couples will receive a survey at baseline 6-, 12-, and 18-month survey, and the investigators will collect ongoing clinical data from each clinic visit. Biometric data (fingerprint) will be collected at study and intervention encounters to link utilization of services with survey data. The investigators will also enroll serodiscordant couples from patients already receiving care from the Kisarawe Care and Treatment Center (CTC).
The specific AIMS evaluate 4 key strategic goals, including:
- HIV Self-Testing for Stable Couples: (a) assess the acceptability, safety, and factors associated with uptake of HIV self-testing; and (b) determine the proportion of clients testing positive for HIV via self-testing who engage in care.
- Dyadic Engagement of Sero-Discordant Couples in Care & Prevention: (a) establish the proportion of sero-discordant couples who will enroll in HIV care as a dyad, (b) determine the effect of dyadic care enrollment on HIV care retention and ART adherence, and (c) assess reduction in risk of acquiring HIV infection for the negative partner.
- Pre-Exposure Prophylaxis (PrEP): (a) establish the proportion and characteristics of HIV negative clients in a sero-discordant relationship who opt to take PrEP, (b) determine how engaging in ARV treatment by the positive partner affects PrEP utilization by the negative partner, and vice versa, and (c) Identify patterns and correlates of risk reduction strategies that couples in care utilize over time (abstinence, ARV for positive partner, PrEP for negative partner, condom use).
- Operational: (a) determine Dyadic-based Diagnosis, Care, & Prevention (DDCP) program cost and economic efficiency, (b) compare DDCP to clinic-based and mobile VCT with regard to cost and efficiency for testing and linkage to care, and (c) assess the feasibility, acceptability, safety, and utility of using biometric data to track service utilization.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pwani
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Dar Es Salaam, Pwani, Tanzania
- Muhimbili University of Health and Allied Programs
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
To be eligible for participation in the self-testing cohort, each individual has to be:
- age 18 years or older (and at least one member of the couple has to be aged 55 years or below),
- live in the household regularly,
- have no plans for moving from the area before the follow up period.
To be eligible for the prevention and care portion of the study, couples must be:
- in an HIV sero-discordant relationship,
- pregnant or breastfeeding women will be allowed to enroll in the study after counseling on the risks and benefits is provided,
- HIV-negative women who are pregnant or breastfeeding will be allowed to take PrEP after counseling on the risks and benefits is provided.
Exclusion Criteria:
Couples will not be eligible for enrolled in the sero-discordant sub-cohort if:
- the HIV-negative member has signs of advanced kidney disease (measured by serum creatinine),
- the HIV-negative partner has Hepatitis B and markers of poor liver functioning (measured by alanine aminotransferase).
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Sero-discordant Couple Cohort
We will enroll and track a cohort of 60 serodiscordant couples (120 individuals).
The HIV-positive couple members will be offered anti-retroviral therapy (ART) and the HIV-negative couple members will be offered pre-exposure prophylaxis (PrEP).
We will monitor monthly clinic visits for the couple and will conduct in-depth behavioral surveys at baseline, 6-, 12-, and 18-months.
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Access to home-based HIV self-testing kits for stable couples.
Immediate access to ART for HIV infected couple members (per current Tanzanian standard of care).
Access to PrEP for HIV uninfected couple members.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Utilization of HIV Self-Test Kits
Time Frame: 2 weeks
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The proportion of eligible individuals who received an HIV self-test kit who successfully used the kit within two weeks of receiving the test kit.
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2 weeks
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Sharing of HIV Test Results with Primary Partner
Time Frame: 18 months
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The self-reported proportion of study participants who told their primary partner the results of the HIV test generated by the self-test kit.
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18 months
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Proportion of HIV Sero-discordant Couples who Engage in HIV Care Together
Time Frame: 18 months
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Proportion of HIV Sero-discordant Couples who Engage in HIV Care Together
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18 months
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Adherence to ART Among HIV Infected Members of Sero-discordant Couples
Time Frame: 18 months
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Self-reported proportion of doses of ART medication successfully taken on recommended schedule.
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18 months
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Retention in ART Care
Time Frame: 18 months
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Having ≥2 outpatient visits at least 3 months apart per year
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18 months
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Uptake of PrEP
Time Frame: 18 months
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Proportion of eligible HIV-uninfected cohort members who opt to take PrEP
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18 months
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Uptake of ARVs
Time Frame: 18 months
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Proportion of eligible HIV-infected cohort members who opt to take ART
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18 months
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Adherence to ART prescription refills among HIV infected members of sero-discordant couples
Time Frame: 18-Months
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Proportion of ART prescriptions successfully filled based on pharmacy records among HIV-infected members of sero-discordant couples.
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18-Months
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HIV Viral Load
Time Frame: 18-months
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Copies per mL of HIV detected in blood sample.
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18-months
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Reduction in HIV-related Risk Behaviors
Time Frame: 18 months
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Self-reported number of sexual partners.
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18 months
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Reduction in sex with non-primary sex partners
Time Frame: 18-Months
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Any self-reported sex with non-primary sexual partner.
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18-Months
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Reduction in sex acts
Time Frame: 18-months
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Self-reported number of vaginal and anal sex acts.
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18-months
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Reduction in unprotected sex
Time Frame: 18-months
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Self-reported proportion of vaginal and anal sex acts in which a condom was used.
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18-months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Program cost per client served
Time Frame: 18 months
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Program cost per client served
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18 months
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R01MH106369-01 (U.S. NIH Grant/Contract)
- R01MH106369 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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