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Clinical Trials/NCT03054051
NCT03054051
Completed
Not Applicable

A Mobile Phone Game to Prevent HIV Among Young Africans

Emory University1 site in 1 country60 target enrollmentMarch 20, 2017
ConditionsHIV/AIDS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV/AIDS
Sponsor
Emory University
Enrollment
60
Locations
1
Primary Endpoint
Number Reporting the Game is Valuable
Status
Completed
Last Updated
6 years ago

Overview

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).

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 20, 2017
End Date
June 19, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kate Winskell

Associate Professor

Emory University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number Reporting the Game is Valuable

Time Frame: Day 17 (post-intervention)

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.

Number of Participants Playing the Game

Time Frame: Day 17 (post-intervention)

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.

Time to Recruitment of 60 Participants

Time Frame: Month 1

The number of days needed to recruit 60 participants.

Number Interested in Participating

Time Frame: Month 1

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.

Number of Participants Feeling Very Safe

Time Frame: Day 17 (post-intervention)

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.

Number of Participants Completing the Study

Time Frame: Duration of Study (Up to 4 Months)

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

Number of Phones Returned

Time Frame: Month 2

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

Number Reporting Game Was Very Fun

Time Frame: Day 17 (post-intervention)

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.

Number of Participants Lost to Follow Up

Time Frame: Duration of Study (Up to 4 Months)

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

Secondary Outcomes

  • 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 Knowledge(Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention)
  • Change in Future Orientation(Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention)
  • Change in Perceived Social Norms(Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention)
  • Change in Self-Efficacy(Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention)
  • Change in Attitudes(Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention)

Study Sites (1)

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