N/A
N=2,102
Secondary Distribution of HIV Self-tests: an Innovative Strategy for Promoting Partner Testing and Reducing HIV Risk
Human Immunodeficiency Virus
Bottom Line
View on ClinicalTrials.gov: NCT03135067 ↗Enrolled (actual)
2,102
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: HIV Incidence Per 100 Person Years — 1.18; .98 cases per 100 person years
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Provision of multiple self-tests (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HIV Incidence Per 100 Person Years |
1.18; .98 | — |
| SECONDARY Identification of HIV-positive Male Partners |
.26; .13 | — |
| SECONDARY Used Condom With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive |
11.6; 6.2; 7.2; 5.2; 5.3; 4.3 | — |
| SECONDARY Couples Testing With Primary Partner |
80.3; 32.9; 75.3; 34.7; 34.7; 26.7 | — |
| SECONDARY Primary Partner Tested for HIV |
87.5; 48.3; 81.2; 48.6; 77.8; 39.8 | — |
| SECONDARY Declined Sex With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive |
14.2; 7.1; 5.1; 6; 4.5; 3.8 | — |
Summary
This cluster randomized trial will assess whether the provision of multiple oral-fluid based HIV self-test kits to HIV-negative women at high risk of acquiring HIV in western Kenya is an approach that promotes HIV testing among women's sexual partners, facilitates better sexual decision making, and reduces women's risk of acquiring HIV.
Eligibility Criteria
Inclusion Criteria
- At least 18 years old
- Currently resides in the study area
- Has resided in the study area for at least 6 months in the year prior to enrollment
- Intends to stay in the study area for at least 24 months
- Reports two or more sexual partners within the past 4 weeks at time of screening
- HIV negative
- Ownership or access to a mobile phone
- Willing and able to provide informed consent
Exclusion Criteria
- Younger than 18 years old
- Does not currently live in the study area or has not for 6 of the last 12 months, or does not plan to for at least the next 24 months
- Fewer than two sexual partners in the last four weeks at time of screening
- HIV positive
- Has no access to a mobile phone
- Enrolled in another HIV prevention study
- Cannot or will not provide informed consent
- Males will self-select to participate by contacting the study staff using the information provided by willing index participants. There are no inclusion or exclusion criteria for the men who select to participate.
Data sourced from ClinicalTrials.gov (NCT03135067). 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.