Tushirikiane HIV-self Testing Intervention With Urban Refugee Youth in Kampala, Uganda

NCT04504097 | Completed DMC

• 1 other identifier: CIHR389142
• Study Type: interventional
• Target: 454
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV/AIDS; HIV Infections; Knowledge, Attitudes, Practice

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

Outcome Measures

Primary Outcomes (5)

• Changes in HIV testing Frequency

  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).

  Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)

• Change in Knowledge of HIV status

  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.

  Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)

• Changes in Linkage to confirmatory HIV testing

  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.

  Time 2 (month 9), Time 3 (month 12)

• Changes in Linkage to HIV care

  Participants who seroconvert during the study are asked the frequency of accessing HIV care services.

  Time 2 (month 9), Time 3 (month 12)

• HIVST kit use

  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.

  Time 3 (month 12)

Secondary Outcomes (5)

• 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 Consistent Condom Use Frequency.

  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 adolescent sexual and reproductive health stigma.

  Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)

Study Arms (3)

HIV self-testing + m-Health

EXPERIMENTAL

At the first visit participants will receive a HIVST kit and a detailed description of how to use the HIVST kits, pictorial and written guide for HIVST kits, condoms and lubricant, in addition to contact information for confirmatory testing and linkage to care at MARPI clinics. We will provide a 24-hour contact number to text, managed through WelTel system that will flag these messages in real-time. Participants will also receive a weekly bidirectional SMS hosted by WelTel to check how they are.

Behavioral: m-Health; Diagnostic Test: HIV self-testing

HIV self-testing

ACTIVE COMPARATOR

At the first visit participants will receive a HIVST kit and a detailed description of how to use the HIVST kits, pictorial and written guide for HIVST kits, condoms and lubricant, in addition to contact information for confirmatory testing and linkage to care at MARPI clinics

Diagnostic Test: HIV self-testing

Standard of Care

NO INTERVENTION

Participants will receive information about HIV testing, care and support services at MARPI clinics and provide a pamphlet of information about HIV \& HIV prevention strategies.

Interventions

m-Health BEHAVIORAL

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.

HIV self-testing + m-Health

HIV self-testing DIAGNOSTIC_TEST

Participants will receive HIVST kits so that they can perform their HIV testing.

HIV self-testing; HIV self-testing + m-Health

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Factor-Inwentash Faculty of Social Work, University of Toronto

Toronto, Ontario, M5S1V4, Canada

Location

Related Publications (2)

• Logie CH, Okumu M, Berry I, Hakiza R, Baral SD, Musoke DK, Nakitende A, Mwima S, Kyambadde P, Loutet M, Batte S, Lester R, Neema S, Newby K, Mbuagbaw L. Findings from the Tushirikiane mobile health (mHealth) HIV self-testing pragmatic trial with refugee adolescents and youth living in informal settlements in Kampala, Uganda. J Int AIDS Soc. 2023 Oct;26(10):e26185. doi: 10.1002/jia2.26185.

  PMID: 37850816 DERIVED

• Logie C, Okumu M, Hakiza R, Kibuuka Musoke D, Berry I, Mwima S, Kyambadde P, Kiera UM, Loutet M, Neema S, Newby K, McNamee C, Baral SD, Lester R, Musinguzi J, Mbuagbaw L. Mobile Health-Supported HIV Self-Testing Strategy Among Urban Refugee and Displaced Youth in Kampala, Uganda: Protocol for a Cluster Randomized Trial (Tushirikiane, Supporting Each Other). JMIR Res Protoc. 2021 Feb 2;10(2):e26192. doi: 10.2196/26192.

  PMID: 33528378 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections; Behavior

Interventions

American Recovery and Reinvestment Act

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Legislation as Topic; Social Control, Formal; Health Care Economics and Organizations

Study Officials

• Carmen Logie, PhD

  University of Toronto, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 7, 2020
• Study Start: November 13, 2019
• Primary Completion: August 20, 2021
• Study Completion: September 20, 2021
• Last Updated: December 28, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1 year after final data collection time point.
• Access Criteria: (1) ability to secure ethics approval from both the user's institution and the University of Toronto research ethics board (2) a commitment to using the data solely for research purposes and not to identify any individual participant; (3) a dedication to securing the data using appropriate computer technology such as encryption; and (4) a commitment to destroying or returning the data after analyses are completed.

Locations

CA (1)