Self-testing for HIV (HIVST) Amongst Urban, Peri-urban and Rural Communities in Zambia, Including a Cluster-randomised Trial of Community-based HIVST Distribution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,005
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Control
All HIV testing and counselling services will be conducted as currently.
HIV Self-Testing
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.
干预措施: Oraquick (made in Thailand) (Device)
结局指标
主要结局
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
时间窗: 12 months
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.
次要结局
- 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(12 months)