Tushirikiane-4-Uthabiti (Supporting Each Other For Resilience)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 432
- 试验地点
- 1
- 主要终点
- Number of participants engaged in HIV testing
研究概览
简要总结
Displaced and refugee youth in Uganda are more vulnerable to health risks due to financial insecurity. As such, the investigators aim to explore the utility of an intervention aimed at improving livelihoods, called Creating Futures. Creating Futures is a group intervention that aims to help young people build their livelihoods, and was designed for use with youth (18-24) in urban informal settlements in South Africa.
Since there is a dearth of knowledge regarding efficacious interventions in refugee camps/settlements to engage young people in HIV testing and linkage to care, the investigators will harness various health promotion techniques including mHealth, comics, and the Creating Futures livelihoods intervention to address the urgent needs for: 1) HIV testing interventions with refugee/displaced adolescent and young people in Kampala, and 2) innovative HIV self test (HIVST) delivery strategies to increase linkage to confirmatory testing and HIV care. The investigators will conduct a three-arm cluster randomized controlled trial (cRCT) to evaluate the effectiveness of HIVST delivery methods among AYP living in Kampala. The specific objectives are to: Evaluate the feasibility and effectiveness of: 1) HIVST alone; 2) HIVST in combination with mHealth; and 3) HIVST, mHealth and Creating Futures in combination in increasing routine HIV testing, HIV status knowledge, and linkage to confirmatory testing and HIV care. The investigators aim to examine if adding a livelihoods program to HIV self-testing improves HIV prevention outcomes and other facets of well-being among urban refugee youth in Kampala.
详细描述
As of March 2021, the prevalence of HIV among Ugandan youth aged 15-24 years was estimated at almost 2%, with young women and adolescent girls having an HIV prevalence over three times that of young men and adolescent boys (2.9% vs. 0.8%). The prevalence of HIV among youth living in Kampala's slums is even higher, at an estimated 13.9-37.2%. This high prevalence may be driven by factors such as food scarcity, limited infrastructure, lack of social support, stigma, and gender norms, which may limit the condom negation and use of HIV testing services among youth. Uganda hosts over 1.5 million refugees, 8% of which reside in Kampala, and many living within slums or informal settlements. While the UNAIDS Gap report identified displaced persons and adolescent girls and young women as populations at high-risk for HIV infection, the HIV prevalence among Uganda's refugees is largely unknown due to the lack of standardized surveillance of refugees.
One approach to improve HIV testing among displaced persons in Uganda is through HIV self-testing (HIVST). HIVST involves a person collecting their own specimen (blood or saliva), conducting the test, and interpreting the results. HIVST has the potential to reduce testing barriers such as stigma and privacy, while enhancing confidentiality and convenience, which are important considerations for adolescents and young people. Innovative HIVST delivery strategies are urgently needed to link persons with positive HIVST results to confirmatory testing and HIV care. As such, identifying strategies to promote linkage to HIV care is essential to realize the public health impact of HIVST. Since there is a dearth of knowledge regarding efficacious interventions in refugee camps/settlements to engage young people in HIV testing and linkage to care, the investigators will harness various health promotion techniques including mHealth, comics, and the Creating Futures livelihoods intervention to address the urgent needs for: 1) HIV testing interventions with refugee/displaced adolescent and young people in Kampala, and 2) innovative HIVST delivery strategies to increase linkage to confirmatory testing and HIV care.
The investigators will evaluate the feasibility and effectiveness of: 1) HIVST alone; 2) HIVST in combination with mHealth; and 3) HIVST, mHealth and Creating Futures in combination in increasing routine HIV testing, HIV status knowledge, and linkage to confirmatory testing and HIV care. The investigators aim to examine if adding a livelihoods program to HIV self-testing improves HIV prevention outcomes and other facets of well-being among urban refugee youth in Kampala.
Mobile health (mHealth) can be used to facilitate HIVST adherence among displaced youth through mobile phone (mHealth) reminders. mHealth approaches are germane to low and middle-income countries (LMIC), where cell phone ownership is rising rapidly, but access to health care is often limited. In Uganda, over 13 million persons have access to mobile phones, and data suggest that HIV prevention messages through mobile phones are beneficial to supplement traditional modalities such as schools for adolescents. Educational comics offer a youth-friendly, low-cost, scalable approach for providing education and health promotion on health topics such as HIV, sexually transmitted infections, vaccines, and dementia. Comics have been used to educate both the general population and healthcare providers to improve care and patient experiences, as they are accessible, do not require high levels of literacy, and can encourage participants to envision and share solutions to sexual violence through facilitating dialogue around emotionally difficult and often stigmatized issues.
Creating Futures is a group intervention that aims to help young people build their livelihoods and was designed for use with youth in urban informal settlements in South Africa. Previous researchers have implemented the Creating Futures intervention in South Africa and found that after the intervention, men's earnings increased, women's experiences of intimate partner violence decreased, men and women scored better on gender attitudes, and depression and suicidal thoughts decreased amongst men.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Living in one of the five selected Kampala informal settlements (Kabalagala, Kansanga, Katwe, Nsambya, or Rubaga)
- •Identify as a displaced person, refugee, or as having a refugee or displaced parent(s)
- •Aged 16-25 years
- •Own or have daily access to a mobile phone
- •Speak French, English, Kirundi, Kinyarwanda, or Swahili
排除标准
- •Not living in one of the five selected informal settlements
- •Does not identify as a displaced person, refugee, or as having a refugee or displaced parent(s)
- •Aged 15 and under or 26 and older
- •Does not have access to a mobile phone or shares a phone
- •Does not speak one of French, English, Kirundi, Kinyarwanda, or Swahili
研究组 & 干预措施
Arm 3: HIVST + mHealth + Creating Futures Livelihoods program
In addition to HIVST and mHealth access, participants in Arm 3 will also be in enrolled in an 8-week Creating Futures program. This manualized program was developed with youth in South Africa and adapted for the Kenyan context (manual is appended). Topics within the Creating Futures program include: 1) introduction and situating self; 2) sustainable and social resources; 3) peer group meeting; 4) education and learning; 5) getting and keeping jobs; 6) income generating activities; 7) saving and coping with shocks; 8) reflection and looking ahead. This intervention aims to help participants think about, and plan for, their futures to assist them in making a living in the long term. Each workshop is facilitated by pairs of peer navigators and runs from 2-4 hours.
干预措施: Creating Futures Livelihoods program (Behavioral)
Arm 1: HIVST Alone
Participants will be provided with HIVST instructions and education from peer navigators, who will also emphasize the importance of receiving a confirmatory test irrespective of HIV positive result. Peer navigators will demonstrate how to use an HIVST kit, including how to 1) open the kit, 2) collect the oral fluid samples, and 3) read the results. In addition to HIVST education, participants will be offered optional pre-test counselling and SMS contact information to connect with their peer navigator. If participants do not want post-test counselling, the PN will follow up within two weeks. If the participants report testing positive, then they will be immediately scheduled for confirmatory testing and enrolled in the support programs at MARPI for young people living with HIV.
干预措施: HIVST (Diagnostic Test)
Arm 2: HIVST + mHealth
Participants in this arm will be enrolled into the HIVST intervention (as described above) as well as mHealth. The mHealth intervention is a 5-week program that includes a: 1) weekly SMS check-in moderated by the peer navigator; 2) weekly themed informational SMS and accompanying questions to enhance engagement; 3) WhatsApp group multi-media sharing with peer navigators. The peer navigator and coordinator will review group discussions weekly to incentivize engagement; 4) participatory comic books. The investigators are collaborating with the WelTel non-profit agency for a supportive SMS intervention. Weekly 2-way supportive messages will automatically be sent on the same weekday with WelTel software to Arm 2+3 participants, who should respond within 48 hours.
干预措施: HIVST (Diagnostic Test)
Arm 2: HIVST + mHealth
Participants in this arm will be enrolled into the HIVST intervention (as described above) as well as mHealth. The mHealth intervention is a 5-week program that includes a: 1) weekly SMS check-in moderated by the peer navigator; 2) weekly themed informational SMS and accompanying questions to enhance engagement; 3) WhatsApp group multi-media sharing with peer navigators. The peer navigator and coordinator will review group discussions weekly to incentivize engagement; 4) participatory comic books. The investigators are collaborating with the WelTel non-profit agency for a supportive SMS intervention. Weekly 2-way supportive messages will automatically be sent on the same weekday with WelTel software to Arm 2+3 participants, who should respond within 48 hours.
干预措施: mHealth (Device)
Arm 3: HIVST + mHealth + Creating Futures Livelihoods program
In addition to HIVST and mHealth access, participants in Arm 3 will also be in enrolled in an 8-week Creating Futures program. This manualized program was developed with youth in South Africa and adapted for the Kenyan context (manual is appended). Topics within the Creating Futures program include: 1) introduction and situating self; 2) sustainable and social resources; 3) peer group meeting; 4) education and learning; 5) getting and keeping jobs; 6) income generating activities; 7) saving and coping with shocks; 8) reflection and looking ahead. This intervention aims to help participants think about, and plan for, their futures to assist them in making a living in the long term. Each workshop is facilitated by pairs of peer navigators and runs from 2-4 hours.
干预措施: HIVST (Diagnostic Test)
Arm 3: HIVST + mHealth + Creating Futures Livelihoods program
In addition to HIVST and mHealth access, participants in Arm 3 will also be in enrolled in an 8-week Creating Futures program. This manualized program was developed with youth in South Africa and adapted for the Kenyan context (manual is appended). Topics within the Creating Futures program include: 1) introduction and situating self; 2) sustainable and social resources; 3) peer group meeting; 4) education and learning; 5) getting and keeping jobs; 6) income generating activities; 7) saving and coping with shocks; 8) reflection and looking ahead. This intervention aims to help participants think about, and plan for, their futures to assist them in making a living in the long term. Each workshop is facilitated by pairs of peer navigators and runs from 2-4 hours.
干预措施: mHealth (Device)
结局指标
主要结局
Number of participants engaged in HIV testing
时间窗: Every 3 months
The primary outcome measured in this trial is routine (every 3 months) HIV testing uptake as a measure of HIV prevention. Participants will be asked to self-report when their last HIV test occurred and where it was received (i.e., HIVST, clinic, point-of-care).
次要结局
- Brief HIV Knowledge Questionnaire(3- and 6-month follow-up)
- Number of participants with knowledge of their HIV status(3- and 6-month follow-up)
- Number of participants linked to confirmatory HIV testing(3- and 6-month follow-up)
- Frequency of linkage to HIV care(3- and 6-month follow-up)
- Sexual Risk(3- and 6-month follow-up)
研究者
Carmen Logie, MSW, PhD
Professor
University of Toronto