N/A
N=6,369
Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT03271307 ↗Enrolled (actual)
6,369
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Aim 1: Proportion of Adult OPD Clients Tested for HIV — 1951; 1837; 2097 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Optimized PITC (Behavioral); Facility HIVST (Diagnostic_test); Index HIVST (Diagnostic_test)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aim 1: Proportion of Adult OPD Clients Tested for HIV |
1951; 1837; 2097 | — |
| PRIMARY Aim 2: Proportion of Sexual Partners Tested for HIV |
107; 258 | — |
| SECONDARY Aim 1: HIV-positivity Rate |
1951; 1837; 2097 | — |
| SECONDARY Aim 1: ART Initiation Among OPD Clients Tested HIV-positive |
1951; 1837; 2097 | — |
| SECONDARY Aim 1: Presence of Non-serious Adverse Events |
1951; 1837; 2097 | — |
| SECONDARY Aim 1: Cost Per Person Initiated ART |
121.02; 156.27; 279.18 | — |
| SECONDARY Aim 2: HIV-positivity Rates Among Sexual Partners Tested for HIV |
107; 258 | — |
| SECONDARY Aim 2: ART Initiation Among Sexual Partners Tested HIV-positive |
107; 258 | — |
| SECONDARY Aim 2: Presence of Non-serious Adverse Events |
107; 258 | — |
| SECONDARY Aim 2: Cost Per Person Tested HIV-Positive |
14.9; 16.11 | — |
| SECONDARY Aim 2: Cost Per Person Initiated ART |
16.11; 68.27 | — |
Summary
This study comprises two trials to evaluate the feasibility and cost-effectiveness of HIV self-testing strategies compared to standard of care among clients in outpatient departments (OPD; Aim 1) and the sexual partners of HIV-positive clients (index testing; Aim 2).
Aim 1 will be a cluster-randomized trial in 15 clusters (high-burden health facilities) in Malawi. We will enroll 6,000 adult OPD clients (15 years or older) to test the feasibility and cost-effectiveness of facility-based HIV self-testing (HIVST) for OPD clients.
Aim 2 will be an individually-randomized trial in 3 high-burden health facilities in Malawi. We will enroll 500 adult HIV-positive clients (15 years or older) to test the feasibility and cost-effectiveness of index HIVST among partners of HIV-positive clients.
Eligibility Criteria
Inclusion Criteria
- 15 years or older
- Willing and able to provide informed consent
- Being seen for OPD services at the time of the study (Aim 1)
- HIV-positive (Aim 2)
- Have at least one sex partner in the catchment area with an unknown HIV status at the time of study enrollment (Aim 2)
Exclusion Criteria
- Currently enrolled in the INTERVAL study
- Guardians attending clinics with OPD clients (Aim 1)
- History of intimate partner violence in the past 12 months (Aim 2)
- Fear of intimate partner violence as a consequence of participating in the study (Aim 2)
Data sourced from ClinicalTrials.gov (NCT03271307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.