Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03271307
• Date of registration: 31/08/2017
• Prospective Registration: Yes
• Primary sponsor: University of California, Los Angeles
• Public title: Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners
• Scientific title: Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners
• Date of first enrolment: September 25, 2017
• Target sample size: 6369
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03271307
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Malawi

Contacts

• Name: Kathryn Dovel, PhD, MPH
• Affiliation: University of California, Los Angeles

Key inclusion & exclusion 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)



Age minimum: 15 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Diagnostic Test: Facility HIVST

Behavioral: Optimized PITC

Diagnostic Test: Index HIVST

Primary Outcome(s)

Aim 2: Proportion of Sexual Partners Tested for HIV [Time Frame: 4-weeks]

Aim 1: Proportion of Adult OPD Clients Tested for HIV [Time Frame: 1 day]

Secondary Outcome(s)

Aim 2: ART Initiation Among Sexual Partners Tested HIV-positive [Time Frame: 3 months]

Aim 2: Cost Per Person Tested HIV-Positive [Time Frame: 1 month]

Aim 1: Presence of Non-serious Adverse Events [Time Frame: as enrollment (measuring adverse events that occurred at the OPD clinic that 1 day)]

Aim 2: Presence of Non-serious Adverse Events [Time Frame: 4-weeks]

Aim 2: Cost Per Person Initiated ART [Time Frame: 3 month]

Aim 1: ART Initiation Among OPD Clients Tested HIV-positive [Time Frame: 3 months]

Aim 1: Cost Per Person Initiated ART [Time Frame: 3 months]

Aim 1: HIV-positivity Rate [Time Frame: Same 1 day as enrollment (measuring HIV testing before clients leave the OPD clinic that day)]

Aim 2: HIV-positivity Rates Among Sexual Partners Tested for HIV [Time Frame: 4-weeks]

Secondary ID(s)

17-000109

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Partners in Hope

Ministry of Health, Malawi

Right to Care

United States Agency for International Development (USAID)

Results

• Results available: Yes
• Date Posted: 02/12/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03271307