This is a prospective observational study of couples in Kisarawe, Tanzania who will be provided an intervention that offers: (1) HIV self-testing kits and pre-test counseling provided at the household, (2) linkage to a counseling and referral center for those who test positive, (3) facilitated enrollment to care and treatment for couples with confirmed HIV infection; and (4) access to pre-exposure prophylaxis for the negative partner in a HIV sero-discordant couple. We will identify HIV sero-discordant couples through the HIV self-testing component, and through identifying discordant couples at the local HIV clinic. HIV sero-discordant couples (N=64 couples) will be administered a 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 enrollment, and all encounters with the counseling and referral center, and HIV treatment center, to allow linking of utilization of services with survey data.
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: 1. 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. 2. 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. 3. 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). 4. 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
OBSERVATIONAL
Enrollment
128
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.
Muhimbili University of Health and Allied Programs
Dar Es Salaam, Coast Region, Tanzania
Utilization of HIV Self-Test Kits
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.
Time frame: 2 weeks
Sharing of HIV Test Results with Primary Partner
The self-reported proportion of study participants who told their primary partner the results of the HIV test generated by the self-test kit.
Time frame: 18 months
Proportion of HIV Sero-discordant Couples who Engage in HIV Care Together
Proportion of HIV Sero-discordant Couples who Engage in HIV Care Together
Time frame: 18 months
Adherence to ART Among HIV Infected Members of Sero-discordant Couples
Self-reported proportion of doses of ART medication successfully taken on recommended schedule.
Time frame: 18 months
Retention in ART Care
Having ≥2 outpatient visits at least 3 months apart per year
Time frame: 18 months
Uptake of PrEP
Proportion of eligible HIV-uninfected cohort members who opt to take PrEP
Time frame: 18 months
Uptake of ARVs
Proportion of eligible HIV-infected cohort members who opt to take ART
Time frame: 18 months
Adherence to ART prescription refills among HIV infected members of sero-discordant couples
Proportion of ART prescriptions successfully filled based on pharmacy records among HIV-infected members of sero-discordant couples.
Time frame: 18-Months
HIV Viral Load
Copies per mL of HIV detected in blood sample.
Time frame: 18-months
Reduction in HIV-related Risk Behaviors
Self-reported number of sexual partners.
Time frame: 18 months
Reduction in sex with non-primary sex partners
Any self-reported sex with non-primary sexual partner.
Time frame: 18-Months
Reduction in sex acts
Self-reported number of vaginal and anal sex acts.
Time frame: 18-months
Reduction in unprotected sex
Self-reported proportion of vaginal and anal sex acts in which a condom was used.
Time frame: 18-months
Program cost per client served
Program cost per client served
Time frame: 18 months
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