Dyadic-Based Diagnosis, Care, and Prevention for HIV Discordant Couples in Tanzania
Condition: HIV
Study type: Observational

Summary: 
      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.
    

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:

        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.
    

Intervention name(s): HIV Self-Testing; Immediate Access to ART for HIV infected couple members; Access to PrEP for HIV uninfected couple members
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cohabitating couples aged 18 to 55 years of age, residing in Kisarawe Town, Tanzania. Our
        cohort will be comprised of HIV sero-discordant couples.
      
Keywords: Serodiscordant; Pre-exposure Prophylaxis; Self-testing; Tanzania