A Mobile Phone Game to Prevent HIV Among Young Africans

NCT ID: NCT03054051

Last Updated: 2019-10-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-20

Study Completion Date

2017-06-19

Brief Summary

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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).

Detailed Description

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This project will test the feasibility of an electronic game for preadolescents, delivered via inexpensive Android smart phones. The game is informed by socio-behavioral and pedagogical theories, evidence-based practice, and formative research on youth sexual culture in sub-Saharan Africa. It is designed to: educate young players, ages 11-14, about sexual health and HIV/AIDS; build risk-reduction skills and related self-efficacy for prevention of HIV, sexually transmitted infections (STIs), and unintended pregnancy; challenge harmful gender norms and HIV stigma; and foster dialogue with parents and caregivers.

The proposed feasibility test will be conducted in Western Kenya. Sixty preadolescents will be enrolled in the trial, 30 in the study arm and 30 in the control arm. The Kenya Medical Research Institute (KEMRI) has established community advisory boards (CABs) in Kisumu, which will be available to the proposed study.

Data collection will take place at KEMRI offices, health clinics, or in the meeting room of a local community-based organization (CBO). In addition, data on game-play will be automatically collected on mobile phones given to preadolescent study participants.

Conditions

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HIV/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Tumaini Mobile Phone Game

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

Group Type EXPERIMENTAL

Tumaini Mobile Phone Game

Intervention Type 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.

Standard of Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tumaini Mobile Phone Game

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

11 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Kate Winskell

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kate Winskell, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Kenya Medical Research Institute

Kisumu, , Kenya

Site Status

Countries

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Kenya

References

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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.

Reference Type RESULT
PMID: 30068501 (View on PubMed)

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.

Reference Type RESULT
PMID: 30916661 (View on PubMed)

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.

Reference Type RESULT
PMID: 31115348 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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5R34MH106368

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00081150

Identifier Type: -

Identifier Source: org_study_id

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