Tushirikiane (Supporting Each Other): Development, Implementation and Evaluation of Novel HIV Self-Testing Delivery Approaches With Urban Displaced and Refugee Adolescents and Youth in Uganda
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 454
- 试验地点
- 2
- 主要终点
- Change in Knowledge of HIV status
研究概览
简要总结
HIV is the leading cause of death for adolescents and young people (AYP) in sub-Saharan Africa (SSA). Uganda hosts 1.3 million refugees/displaced persons, and more than 80,000 live in Kampala, most in slums, yet little is known of HIV testing and prevention needs with displaced/refugee AYP living in Kampala's slums. This study aims to develop, implement and evaluate an oral HIV-self testing (HIVST) intervention with displaced/refugee AYP aged 16- 24 in Kampala. HIVST is acceptable and properly used with AYP in other SSA regions, yet there are knowledge gaps regarding the best way to link HIVST to HIV care. This study aims to explore how m-health (healthcare delivered on mobile-phones), congruent with how AYP learn and socialize, can improve linkage to care with HIVST. This trial focuses on implementing a cluster randomized trial with displaced/refugee AYP aged 16-24 living in informal settlements in Kampala (Arm1: HIVST; Arm 2: HIVST + m-health; Arm 3: standard of care). The study will assess changes in HIV testing practices, HIV status knowledge, and linkage to HIV prevention and care between the 3 arms.
详细描述
The proposed study will take place in Kampala, Uganda, hosting over 80,000 refugees. This research will be conducted in 5 informal settlements ('slums') grouped into 3 clusters based on proximity (1: Kabalanga and Kasanga, 2: Katwe and Nsambya, 3: Rubaga) where most displaced/refugee persons in Kampala live.
The proposed intervention involves a cluster randomized controlled trial (cRCT) to evaluate the effectivness of HIVST delivery approaches on HIV testing uptake among refugee youth aged 16-24 in Kampala. Clusters include 3 sites, slums of: Kabalanga/kasanga, Katwe/Nsambya and Rubaga. Sites will be randomized in a 1:1:1 method to one of 3 study arms:
Arms 1 & 2: HIVST Interventions: At the first visit study participants are provided with a HIVST kit (Oraquick: approved and used in Uganda by the Ministry of Health) that is an oral swab test stick and tube solutions, and a written detailed step by step description of how to correctly use the HIVST kits, pictorial and written guide for HIVST kits, condoms and lubricant, information booklets on HIV and testing, referral cards with addresses and phone numbers to MARPI clinics for confirmatory testing. The cards will also have a peer navigator (PN)'s phone numbers for participants to text message (SMS) if they need additional information on how to use the kits, or support to go to confirmatory tests at the MARPI clinics. Instructions for the kits are in French, Swahili, Luganda and English and reflect the context of the urban displaced adolescent and young people. There is a 24-hour contact number for participants to text if/when they have questions. These texts will be managed through WelTel system that will flag these messages in real-time. The Research Coordinator and PN team will rotate being on-call to respond to these issues by text and will offer to phone, text, or WhatsApp support the participant and offer to make an appointment to see them and/or support them to attend MARPI or collaborating agency for further support. At follow-up visits PN will check in with participants about the HIVST kits, distribute another HIVST kit and condoms/lubricant, and screen for adverse events (e.g. negative HIVST related experiences).
Arm 2: HIVST + m-Health: Participants will receive weekly text messages via WelTel that check in with their wellbeing. Arm 2 PNs will discuss the weekly two-ways messages with participants, and request participants to respond to the message (detailed above) within 2 days.
Arm 3: Standard of Care: PNs will provide information about HIV testing, care and support services at MARPI clinics and provide a pamphlet of information about HIV & HIV prevention strategies (written in French, English, Luganda and Swahili).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •live in one of the 5 slum/informal settlement sites (Kabalanga, Kasanga, Katwe, Nsambya Rubaga)
- •identify as a refugee/displaced person or have refugee parents
- •aged 16-24
- •report HIV negative status at baseline
- •own or have access to a mobile phone for the study.
- •Exclusion criteria:
- •report HIV-positive status at baseline
- •do not identify as refugee or do not have refugee parents have no mobile phone do not live in the 5 selected slums
排除标准
- 未提供
结局指标
主要结局
Change in Knowledge of HIV status
时间窗: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
To address social desirability bias challenges regarding self-reported HIV serostatus there are multiple steps employed. First, at Time 1 and Time 2 participants are asked their current HIV status. Second, participants are offered a completely voluntary rapid HIV test (Alere). Knowledge of HIV status will be assessed as correct for persons who agree to take the rapid test and correctly report their HIV status.
Changes in Linkage to confirmatory HIV testing
时间窗: Time 2 (month 9), Time 3 (month 12)
For arms 1 \& 2 participants at Time 2 and Time 3 are asked if they used their HIVST kit; for those who respond affirmatively they will be asked the result, and those who report a positive result will be asked if and where they received confirmatory testing.
HIVST kit use
时间窗: Time 3 (month 12)
To understand the frequency of kit use by m-health arm, and to reduce social desirability bias regarding HIVST kit use, Arm 1 \& 2 participants will be followed up one month after T3 to request to purchase unused kits back. Participants will not be informed of this as an option prior to this time.
Changes in HIV testing Frequency
时间窗: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
To assess changes in past 3 month HIV testing frequencies, participants are asked to self-report when their last HIV test was and where their last HIV test was (if they used the HIVST, clinic, or point-of-care testing).
Changes in Linkage to HIV care
时间窗: Time 2 (month 9), Time 3 (month 12)
Participants who seroconvert during the study are asked the frequency of accessing HIV care services.
次要结局
- Changes in adolescent sexual and reproductive health stigma.(Time 1 (month 0), Time 2 (month 9), Time 3 (month 12))
- Changes in HIV stigma(Time 1 (month 0), Time 2 (month 9), Time 3 (month 12))
- Changes in Safer Sex Self-Efficacy.(Time 1 (month 0), Time 2 (month 9), Time 3 (month 12))
- Changes in Sexual Relationship Power(Time 1 (month 0), Time 2 (month 9), Time 3 (month 12))
- Changes in Consistent Condom Use Frequency.(Time 1 (month 0), Time 2 (month 9), Time 3 (month 12))
研究者
Carmen Logie, MSW, PhD
Associate Professor
University of Toronto