NCT03098693

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

November 21, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2020

Completed
Last Updated

February 7, 2022

Status Verified

January 1, 2022

Enrollment Period

2.8 years

First QC Date

March 22, 2017

Last Update Submit

January 21, 2022

Conditions

HIV

Keywords

SerodiscordantPre-exposure ProphylaxisSelf-testingTanzania

Outcome Measures

Primary Outcomes (13)

  • 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.

    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.

    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

    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.

    18 months

  • Retention in ART Care

    Having ≥2 outpatient visits at least 3 months apart per year

    18 months

  • Uptake of PrEP

    Proportion of eligible HIV-uninfected cohort members who opt to take PrEP

    18 months

  • Uptake of ARVs

    Proportion of eligible HIV-infected cohort members who opt to take ART

    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.

    18-Months

  • HIV Viral Load

    Copies per mL of HIV detected in blood sample.

    18-months

  • Reduction in HIV-related Risk Behaviors

    Self-reported number of sexual partners.

    18 months

  • Reduction in sex with non-primary sex partners

    Any self-reported sex with non-primary sexual partner.

    18-Months

  • Reduction in sex acts

    Self-reported number of vaginal and anal sex acts.

    18-months

  • Reduction in unprotected sex

    Self-reported proportion of vaginal and anal sex acts in which a condom was used.

    18-months

Secondary Outcomes (1)

  • Program cost per client served

    18 months

Study Arms (1)

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.

Behavioral: HIV Self-TestingBehavioral: Immediate Access to ART for HIV infected couple membersBehavioral: Access to PrEP for HIV uninfected couple members

Interventions

HIV Self-TestingBEHAVIORAL

Access to home-based HIV self-testing kits for stable couples.

Sero-discordant Couple Cohort
Immediate Access to ART for HIV infected couple membersBEHAVIORAL

Immediate access to ART for HIV infected couple members (per current Tanzanian standard of care).

Sero-discordant Couple Cohort
Access to PrEP for HIV uninfected couple membersBEHAVIORAL

Access to PrEP for HIV uninfected couple members.

Sero-discordant Couple Cohort

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhimbili University of Health and Allied Programs

Dar Es Salaam, Coast Region, Tanzania

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director, Division of Global and Community Health, Director of MUSC Center for Global Health

Study Record Dates

First Submitted

March 22, 2017

First Posted

April 4, 2017

Study Start

November 21, 2017

Primary Completion

September 7, 2020

Study Completion

September 7, 2020

Last Updated

February 7, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

TA(1)