Community-based Distribution of Oral HIV Self-testing Kits

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02994329
• Date of registration: 30/11/2016
• Prospective Registration: Yes
• Primary sponsor: Zambart
• Public title: Community-based Distribution of Oral HIV Self-testing Kits
• Scientific title: Community-based Distribution of Oral HIV Self-testing Kits-A Pilot Intervention and Rapid Impact Evaluation
• Date of first enrolment: January 18, 2017
• Target sample size: 8080
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02994329
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Zambia

Contacts

• Name: Alwyn Mwinga, PhD
• Affiliation: Zambart

Key inclusion & exclusion criteria

Inclusion Criteria:

- Resident in CHW zone

- Aged 16 years and above

Exclusion Criteria:

- age <16

- unable to provide informed consent



Age minimum: 16 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV Seropositivity

Intervention(s)

Device: OraQuick® HIV Self-Test (Orasure Technologies, Thailand)

Primary Outcome(s)

The proportion of the total resident adult population who know their HIV status [Time Frame: 3 Months]

Secondary Outcome(s)

Proportion of adults who test for HIV amongst those eligible for testing [Time Frame: 3 Months]

Proportion of couples who test for HIV and receive results as a couple [Time Frame: 3 Months]

Proportion of resident adolescent population who consent to participate in the intervention [Time Frame: 3 Months]

Proportion of all adults who consent to participate in the intervention who know their HIV status [Time Frame: 3 Months]

Reported social harms associated with HIV testing [Time Frame: 3 Months]

Proportion of resident adult population who have previously not been reached by the PopART intervention who consent to participate in the intervention [Time Frame: 3 Months]

Factors associated with uptake of and experience with HIV self testing [Time Frame: 3 Months]

Proportion of total resident adult population who consent to participate in the intervention [Time Frame: 3 Months]

Incremental cost effectiveness of the addition of oral HIV self testing into a package of door-to- door HIV testing provided by CHW [Time Frame: 3 Months]

Linkage to HIV prevention and care [Time Frame: 3 Months]

Proportion of male resident adult population who consent to participate in the intervention [Time Frame: 3 Months]

Secondary ID(s)

HIV-SELF 3IE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

London School of Hygiene and Tropical Medicine