Tushirikiane HIV-self Testing Intervention With Urban Refugee Youth in Kampala, Uganda
Condition: HIV/AIDS; HIV Infections; Knowledge, Attitudes, Practice
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).

      Participant retention: Community collaborators will facilitate recruitment and retention; PNs
      will use multiple study reminder strategies (e.g. social media, texts) to maintain
      engagement, and we will utilize existing outreach and services by MARPI, YARID, Interaid
      Uganda, Tomorrow Vijana and community partners.

      Research Team Training: This research involves collaborations with the Ministry of Health's
      Most At Risk Population Initiative (MARPI) clinics, YARID's women empowerment centre,
      Tomorrow Vijana's and Interaid Uganda's urban outreach programs in Kampala. MARPI clinic
      staff will provide technical assistance for HIVST and train PN and the research team in: a)
      using HIV rapid test kits (Alere Determine HIV-1/2); b) using OraQuick, a rapid oral HIVST
      used in Uganda; c) pre/post HIV test counseling; and d) linkages to confirmatory testing and
      HIV care.

      m-Health training: This research involves a collaboration with WelTel's non-profit agency for
      the supportive SMS intervention (Arm 2). WelTel staff will conduct SMS training with:
      Research Coordinator, Logie, Okumu, and the research team, including the PN. The WelTel
      system will manage the SMS intervention on their structured mobile-phone platform (all SMS
      interactions are logged). Weekly 2-way supportive messages (how are you? In Swahili: Habari
      Yako?) will automatically be sent on the same weekday with WelTel software to Arm 2
      participants. PN ask Arm 2 participants to respond within 48 hours if they are well (Mzuri
      sana) or have a problem (Nina shida), and will follow-up with non-responders. The Arm 2 PN
      and Research Coordinator will access the server every 24-48 hours to triage and respond to
      participants who express a problem or need.

      Linkage to testing and care: Participants across all study arms will meet with PN at 3 time
      points (t0: baseline, t1: 8 months, t2: 12 months) to complete surveys. Each participant will
      have a study identification (ID) number printed on 'movie coupons'; they can bring these
      coupons to MARPI for HIV testing, confirmatory testing, linkage to HIV care, SRH services.
      The survey ID will be linked to resources accessed. Persons who test positive will be linked
      with the collaborator Uganda Network of Young People Living with HIV & AIDS (UNYPA)'s support
      groups and services.
    

Intervention name(s): m-Health; HIV self-testing
Intervention type(s): Behavioral; Diagnostic Test
Intervention description(s): Participants receive a weekly bidirectional text message (SMS) asking how they are doing. They are requested to reply fine, or not fine, in which case they will be contacted with support by a peer navigator. If they do not reply to the message within the specified timeframe a peer navigator will follow up with them.; Participants will receive HIVST kits so that they can perform their HIV testing.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This cluster randomized controlled trial (cRCT) will evaluate the effectivness of HIVST delivery approaches on HIV testing uptake among refugee youth in Kampala. Clusters include 3 sites, informal settlements. Sites will be randomized in a 1:1:1 method to one of 3 study arms: Arm 1-HIVST, Arm 2- HIVST+ m-health, and Arm 3-standard of care (control). We propose a cRCT design of randomizing by slums to reduce the possibility of experimental contamination due to the shared social and physical environment in slums. Data collectors will administer tablet-based surveys (baseline, t1: 8 months, t2: 12 months). Arms 1 & 2 will receive HIVST kits at each time-point.
Masking: None (Open Label)
Primary purpose: Screening
Keywords: HIV self testing; Forcibly displaced youth; mhealth; HIV prevention; Uganda; informal settlements; linkage to confirmatory testing; routine HIV testing; HIV status knowledge; HIV care