Human Immunodeficiency Virus (HIV) Prophylaxis, Tuberculosis (TB)
Conditions
Keywords
Uganda, TB contact tracing, HIV, Tuberculosis, PrEP, Household
Brief summary
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.
Interventions
OTHERHome-based HIV self-testing
Integration of HIV self-testing into TB household contact investigation
OTHERHome-based initiation of PrEP
Integration of PrEP initiation into TB household contact investigation
Sponsors
University of Washington
Infectious Diseases Institute, Uganda
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Household randomized implementation study
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP uptake | From enrollment to the one-month follow-up visit | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP continuation | From enrollment to six-month follow-up visit | Proportion of participants initiating PrEP with detectable tenofovir in urine samples at three- and six-month visits |
| HIV testing coverage | From enrollment to six-month follow-up visit | Proportion of participants known to be living with HIV or have tested HIV-negative among all participants |
Countries
Uganda
Contacts
CONTACTJennifer M Ross, MD, MPH
PRINCIPAL_INVESTIGATORJennifer M Ross, MD, MPH
University of Washington
Outcome results
None listed