HIV Self-Testing Africa Zambia

Study Overview
=================
Brief Summary
-----------------
This study consists of a Cluster Randomised Trial (CRT) of community and facility-based HIVST distribution by the Society for Family Health (SFH) in multiple rural and peri-urban settings. The study will take place in 6 matched pairs of health facilities and their catchment areas have been selected for study inclusion in collaboration with the district medical office (DMO). One clinic catchment area from each pair will be randomly allocated to the HIVST arm (intervention) and the other to the standard of care (SOC) arm (Control).In the HIVST arm, community-based distribution agents (CBDA), including Voluntary Medical Male Circumcision (VMMC) mobilisers, will deliver HIVST kits. The kits will also be available at the health facility. In the SOC arm, all HIV testing and counseling (HTC) services will be conducted as currently.

Detailed Description
-----------------
The study will use the OraQuick® HIV Self-Test (Orasure Technologies, Thailand). The kits contain the HIV Oral Fluid Test (HIVOFT) test kit, stand, buffer solution, locally-translated instructions for use (IFUs), materials on counselling and linkage to care, and primary and secondary packaging. The kits will be distributed for free by CBDAs. Leaflets will be provided in lieu of patient information sheets, but no other consent will be required for HIVST implementation. Following baseline enumeration, clinic pairs will be randomly allocated to either the intervention or control arm at a public ceremony. An opaque bag containing 2 balls - one for HIVST and one for SOC - will be used to allocate the HIVST arm. It will not be possible to blind participants, CBDAs, or their supervisors to the cluster intervention allocation, but all forms will be managed without reference to the intervention arm. Outcome data will not be analysed until completion of the trial, with the exception of data analysis by an independent statistician for presentation to the Trial Advisory Group. CBDAs linked to intervention clinics will be provided with training in HIVST and Information, Education and Communication (IEC) materials including flipcharts, used kits to show clients how to interpret positive, negative and inconclusive results, a cotton bud and vial of water to demonstrate the mouth swabbing and development process, leaflets and a buffer stock of OraQuick® HIV Self-Test to be stored in a locked container in their own home. Older adolescent and adult participants (age 15 - 17years or older) wishing to know their status will be provided with information on where to obtain further counselling and care together with the kit, and an envelope for return of the used kit, a self-completed questionnaire (SCQ), a self-referral slip for the nearest clinic in case of a positive result, and information on how to access VMMC for HIV-negative men. Clients will be encouraged to return their used kits confidentially to the CBDA, either in person or by posting in the sealed envelope into an opaque locked ballot box container kept in/at the CBDA's/counsellor's house. Clients will also be encouraged to seek post-test advice from the CBDA, which can be generic or results-based. Kits will be replaced by the clinic supervisors on presentation of used kits and following inspection of an HIV test logbook to confirm recording of names and addresses, but not results, of clients. Numbers of used kits, and re-read results, will be recorded by the CBDA/clinic supervisor. HIVST logbooks will be kept at the CBDA's home in a locked container. Couple's testing will be encouraged. In the case of couples wanting to self-test together, both partners will be asked to attend the IEC session. Clients will be allowed to take up to 2 kits home if the partner cannot attend. Testing of children (aged 15 years or less) will not be permitted as part of this trial, but can be arranged through special arrangement with SFH supervisors. There are no sharps or hazardous materials that will be used in this study. BASELINE SURVEY SAMPLING AND INCLUSION/EXCLUSION CRITERIA Sample size calculations Baseline enumeration will include approximately 2400 participants in the intervention communities (400 per community) and 2,400 participants in the control communities (n= 4,800). Within this sample, 20% of participants ( 1,000) will be randomly selected for the extended baseline survey. The sample size justification for the extended questionnaire is detailed below. The sample size was calculated to ensure 80% power to detect a 50% change in the proportion of individual tested for HIV over the last twelve months, with 95% confidence. Using 2013-2014 Demongraphic and Health Survey (DHS) data, baseline rates for individuals tested in the last 12 months are estimated to be between 28.6-57.1% (lower in men than women); for this sample calculation, we have assumed a baseline testing rate of 50%. For a two-sample comparison of matched proportions across 6 pairs of matched communities, we estimate that it will be necessary to recruit around 400 respondents per community, or 4,800 respondents in total.

Official Title
-----------------
Self-testing for HIV (HIVST) Amongst Urban, Peri-urban and Rural Communities in Zambia, Including a Cluster-randomised Trial of Community-based HIVST Distribution

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Device: Oraquick (made in Thailand)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (≥ 18 years old) Adolescents (16 and 17 years old) Able and willing to provide informed consent Residing within catchment area of a designated local health unit Residing in a randomly selected household Exclusion Criteria: Unable and unwilling to provide informed consent Residing outside the catchment area. Anything that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>All HIV testing and counselling services will be conducted as currently. | |
| Experimental: HIV Self-Testing<br>Community-based distribution agents (CBDA), including Voluntary Male Medical Circumcision (VMMC) mobilisers, will deliver OraQuick® HIV Self-Tests (Orasure Technologies, Thailand). The kits will also be available at the health facility. | Device: Oraquick (made in Thailand)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between randomisation arms in coverage of recent (within the last 12 months) HIV testing among older adolescents and adults (aged from 16 years) in the clinic catchment areas 12 months after the start of the intervention - by self-report | Recent testing will be measured by self-report and analyzed at the individual level. Respondents will be asked to answer the following question: Have you tested for HIV within the past 12 months as part of the baseline, midline, and endline surveys. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between randomisation arms of antiretroviral therapy (ART) initiation rates for older adolescent and adult (aged from 16 years) cluster residents, during months 1 to 12 of the intervention - measured using clinic data | Linkage to HIV care will be measured using clinic data. Self-testers will receive self-referral forms, and will be asked to bring these to clinics where they receive confirmatory testing and care. Clinic staff will log all clients seeking confirmatory testing following HIV self-testing. Data on linkage will be aggregated to the clinic level for analysis. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV self-testing, HIV, Zambia