Social Skills Clinical Trial
Official title:
Tushirikiane-4-Uthabiti (Supporting Each Other For Resilience)
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.
Status | Recruiting |
Enrollment | 432 |
Est. completion date | December 31, 2024 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years to 25 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Uganda | Young African Refugees for Integral Development | Kampala |
Lead Sponsor | Collaborator |
---|---|
University of Toronto |
Uganda,
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* Note: There are 50 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants engaged in HIV testing | 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). | Every 3 months | |
Secondary | Number of participants with knowledge of their HIV status | Since HIV status is self-reported, the investigators will use multiple steps to overcome challenges of social desirability bias. First, interviewers will ask participants to report their current HIV status at 3- and 6-month follow-up. Second, the trained interviewer will offer participants a voluntary rapid HIV test (Alere). Knowledge of HIV status will be assessed as correct for participants who agree to take the rapid test and correctly report their HIV status. The investigators will also record if participants were willing to take the interviewer administered rapid test. | 3- and 6-month follow-up | |
Secondary | Number of participants linked to confirmatory HIV testing | Participants will be asked if they used their HIVST kit at 3- and 6-month follow-up. For those who affirm use of HIVST kits with a positive test result, the investigators will ask if and where they received a confirmatory test. Participants can receive confirmatory testing without reporting to the interviewer and can submit coupons at MARPI or to local clinics. | 3- and 6-month follow-up | |
Secondary | Frequency of linkage to HIV care | The investigators will ask participants who seroconvert during the study to report the frequency of HIV care services. In addition, participants can present coupons when accessing MARPI or local clinic services. | 3- and 6-month follow-up | |
Secondary | Brief HIV Knowledge Questionnaire | The investigators will use the18-item dichotomous response (true/false) to assess HIV Knowledge. A score of 0 is recorded for 'false' responses and 1 for 'true responses. A higher total score indicates better knowledge of HIV. | 3- and 6-month follow-up | |
Secondary | Sexual Risk | The investigators will assess sexual risk through self-reported measures of consistent condom use (anal, vaginal sex) with regular, causal, and paid sex partners in the past month, as well as the number of sex partners in the past month, condom use self-efficacy, and selling sex in the past 3 months | 3- and 6-month follow-up |
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