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Integrating HIV Prevention With TB Household Contact Evaluation in Uganda

ConditionsTuberculosis (TB)Human Immunodeficiency Virus (HIV) Prophylaxis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15+
SponsorUniversity of Washington

About this trial

This household randomized implementation study assesses the implementation and effectiveness of home-based HIV self- testing and PrEP initiation versus standard clinic referral for PrEP initiation during modified standard-of-care (modified SOC) household TB contact investigation in Uganda. It uses qualitative methods to evaluate the process of implementing the intervention and a health economic evaluation to assess the financial sustainability of this strategy.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Person with pulmonary TB OR live in a household with someone with pulmonary TB being treated at one of the participating health facilities

Household includes ≥2 persons

Age 15 years and older

Willingness to participate in study procedures

Disqualifiers

Lives in a congregate setting (e.g., dormitory or jail)

Lives outside the study area

Any other condition that, in the opinion of the Investigator/designee, could preclude informed consent, make study participation unsafe, or otherwise interfere with achieving study objectives

Trial design

Design model

Parallel

Treatments tested in this trial

  • Home-based HIV self-testing

    Other intervention

    Integration of HIV self-testing into TB household contact investigation

  • Home-based initiation of PrEP

    Other intervention

    Integration of PrEP initiation into TB household contact investigation

Treatment groups

2,480 Participants
are divided into 2 treatment groups
Group A: Home-based HIV self-testing and PrEP initiationExperimental treatment 2 interventions
Group B: Modified standard of careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

PrEP uptake

Uptake of PrEP among eligible household members, measured as the proportion initiating PrEP by 1 month and found to have detectable tenofovir use at the one-month visit

Time frame
From enrollment to the one-month follow-up visit

Secondary outcomes

1

PrEP continuation

Proportion of participants initiating PrEP with detectable tenofovir in urine samples at three- and six-month visits

Time frame
From enrollment to six-month follow-up visit
2

HIV testing coverage

Proportion of participants known to be living with HIV or have tested HIV-negative among all participants

Time frame
From enrollment to six-month follow-up visit

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

Infectious Diseases Institute, Uganda

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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