A Mobile Phone Game to Prevent HIV Among Young Africans

NCT03054051 | Completed Results

• 2 other identifiers: IRB000811505R34MH106368
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This project will test the feasibility of an electronic game to prevent HIV among African preadolescents, delivered via inexpensive Android smart phones. In order to collect feasibility data for a future randomized controlled trial, this study involves the pilot-testing of the intervention with a sample of young people in Nyanza region, Kenya, where 11.4% of young women ages 15-24 are HIV-infected. This feasibility study will be carried out with the Kenya Medical Research Institute (KEMRI).

Conditions

HIV/AIDS

Keywords

HIV prevention; Preadolescence; Mobile phone game; Feasibility

Outcome Measures

Primary Outcomes (9)

• Number Interested in Participating

  To evaluate the feasibility of conducting a technology based intervention in a low resource area, the number of eligible individuals who were interested in participating after hearing about the study was examined. Letters were sent to 150 families inviting them to attend an informational meeting and 126 attended a meeting and were assess for eligibility.

  Month 1

• Time to Recruitment of 60 Participants

  The number of days needed to recruit 60 participants.

  Month 1

• Number of Participants Lost to Follow Up

  The number of participants who consented to participate but then later could not be reached prior to completing all study visits.

  Duration of Study (Up to 4 Months)

• Number of Participants Completing the Study

  The number of participants who completed all study visits after providing consent are presented here.

  Duration of Study (Up to 4 Months)

• Number of Phones Returned

  The phone retention rate (phones not lost during the intervention) was assessed by the number of phones returned at the end of the intervention.

  Month 2

• Number Reporting Game Was Very Fun

  Game acceptability was assessed by asking participants how fun playing the game was. The number of participants reporting that the game was "very fun" are presented here.

  Day 17 (post-intervention)

• Number Reporting the Game is Valuable

  The value of the game was assessed with several questions regarding how much the participants learned and how useful the information is. The number of participants reporting that they learned a lot, found the information very useful now, and found the information very useful for the future, are presented below.

  Day 17 (post-intervention)

• Number of Participants Feeling Very Safe

  Personal safety associated with being in possession of the phone was assessed by the post-intervention survey. Phones provided for the intervention were set up so that all other features were blocked and only function the phone could perform was playing the game.

  Day 17 (post-intervention)

• Number of Participants Playing the Game

  Participants were asked to play the game for at least one hour per day for 16 days. The number of participants who reported playing the game everyday and the number of participants who reported playing the game for an hour or more each time are presented here.

  Day 17 (post-intervention)

Secondary Outcomes (7)

• Change in Knowledge

  Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention

• Change in Self-Efficacy

  Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention

• Change in Risk Assessment

  Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention

• Change in Behavioral Intention

  Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention

• Change in Future Orientation

  Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention

Study Arms (2)

Tumaini Mobile Phone Game

EXPERIMENTAL

Participants randomized to this arm will be invited to play the Tumaini game.

Behavioral: Tumaini Mobile Phone Game

Standard of Care

NO INTERVENTION

Participants randomized to this arm will receive no intervention beyond the current standard of care for sexual education.

Interventions

Tumaini Mobile Phone Game BEHAVIORAL

Tumaini is a scenario-based role-playing game application, optimized for use on low-cost Android smartphones. Participants will be invited to play the game for at least ten hours over a period of three weeks. The game is designed to: educate players about sexual health and HIV/AIDS; build risk-reduction skills and related self-efficacy for prevention of HIV/STIs and unintended pregnancy; challenge HIV stigma and harmful gender norms; and promote parent-child dialogue.

Tumaini Mobile Phone Game

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged 11-14 at time of recruitment
• Resident in Nyanza region, Kenya
• Having basic literacy in English
• Only one child enrolled per family

You may not qualify if:

• Aged \<11 or \>14 at time of recruitment
• Not resident in Nyanza region, Kenya
• Without basic literacy in English
• Sibling to a child already enrolled in the study
• Participant in formative research to inform the study

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator
• Kenya Medical Research Institute: collaborator

Study Sites (1)

Kenya Medical Research Institute

Kisumu, Kenya

Location

Related Publications (3)

• Winskell K, Sabben G, Akelo V, Ondeng'e K, Obong'o C, Stephenson R, Warhol D, Mudhune V. A Smartphone Game-Based Intervention (Tumaini) to Prevent HIV Among Young Africans: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Aug 1;6(8):e10482. doi: 10.2196/10482.

  PMID: 30068501 RESULT

• Sabben G, Akelo V, Mudhune V, Ondeng'e K, Ndivo R, Stephenson R, Winskell K. A Smartphone Game to Prevent HIV Among Young Africans: Protocol for a Randomized Pilot Study of a Mobile Intervention. JMIR Res Protoc. 2019 Mar 27;8(3):e11209. doi: 10.2196/11209.

  PMID: 30916661 RESULT

• Sabben G, Mudhune V, Ondeng'e K, Odero I, Ndivo R, Akelo V, Winskell K. A Smartphone Game to Prevent HIV Among Young Africans (Tumaini): Assessing Intervention and Study Acceptability Among Adolescents and Their Parents in a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 May 21;7(5):e13049. doi: 10.2196/13049.

  PMID: 31115348 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; 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

Results Point of Contact

• Title: Kate Winskell Enger PhD
• Organization: Emory University

swinske@emory.edu

404-727-5286

Study Officials

• Kate Winskell, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 15, 2017
• Study Start: March 20, 2017
• Primary Completion: June 19, 2017
• Study Completion: June 19, 2017
• Last Updated: October 17, 2019
• Results First Posted: October 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)