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A Mobile Phone Game to Prevent HIV Among Young Africans

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Tumaini Mobile Phone Game
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV/AIDS focused on measuring HIV prevention, Preadolescence, Mobile phone game, Feasibility

Eligibility Criteria

11 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kenya Medical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tumaini Mobile Phone Game

Standard of Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
Time to Recruitment of 60 Participants
The number of days needed to recruit 60 participants.
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.
Number of Participants Completing the Study
The number of participants who completed all study visits after providing consent are presented here.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Change in Knowledge
Knowledge measures will be assessed via Yes/No survey questions and will address puberty, HIV, sexually transmitted infections (STIs), pregnancy, condoms, and alcohol and drugs. Knowledge was assessed with 15 items and responses are coded as 0 or 1. Total scores range from 0 to 15, with higher scores indicating increased knowledge. A positive value for the change from baseline score indicates an increase in knowledge from the baseline assessment.
Change in Self-Efficacy
Self-efficacy was assessed via a 3-point Likert scale, and addressed self-efficacy to seek advice about puberty, sex, relationships; to communicate about protected sex; to reject peer, partner and adult pressure to engage in risk behaviors. Self-efficacy was assessed with 9 items which were scored as 0, 0.5 or 1. Total scores ranged from 0 to 9, with higher scores indicating increased self-efficacy. A positive value for the change from baseline score indicates an increase in self-efficacy since the baseline assessment.
Change in Risk Assessment
Risk assessment was assessed via a 3-point Likert scale, and addressed perceived risk of certain risk situations/behaviors and of contracting HIV. Risk is assessed with 4 items and responses are coded as 0, 0.5 or 1. Total scores range from 0 to 4, with higher scores indicating increased risk assessment. A positive value for the change from baseline score indicates an increase in assessing risky situations as risky.
Change in Behavioral Intention
Behavioral intention was assessed via Yes/No questions. The measure addressed intention to seek advice, to avoid risk situations, and to engage in health protective behaviors. Behavioral intention is assessed with 6 items that are scored as 0 or 1 and total scores range from 0 to 6. Higher scores in indicate more intention to partake in health protective behaviors and a positive value for the change from baseline score indicates a desirable change in intention.
Change in Future Orientation
Future orientation was assessed via a single multiple-choice question (Yes/No/Maybe) and addressed perceived locus of control. Response is coded as 0, 0.5, or 1 and higher scores indicate greater understanding of future locus of control. A positive value for the change from baseline score indicates a desirable change in scores.
Change in Perceived Social Norms
Perceived social norms were assessed via a 3-point Likert and addressed sex, gender, condoms, and HIV stigma. Social norms were assessed with 6 items that are scored as 0, 0.5, or 1. Total scores range from 0 to 6 with higher scores indicating perception of more desirable social norms. A positive value for the change from baseline scores indicates a desirable change.
Change in Attitudes
Attitudes were assessed via 3-pt Likert survey questions relating to HIV stigma, condoms, sex, gender, and future orientation. Attitudes were assessed with 15 items and responses coded as 0, 0.5, or 1. Total scores ranged from 0 to 15, with higher scores indicating more desirable attitudes. A positive value for the change from baseline score indicates an increase in desirable attitudes.

Full Information

First Posted
February 13, 2017
Last Updated
September 23, 2019
Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH), Kenya Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03054051
Brief Title
A Mobile Phone Game to Prevent HIV Among Young Africans
Official Title
A Mobile Phone Game to Prevent HIV Among Young Africans
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
June 19, 2017 (Actual)
Study Completion Date
June 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH), Kenya Medical Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
HIV prevention, Preadolescence, Mobile phone game, Feasibility

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tumaini Mobile Phone Game
Arm Type
Experimental
Arm Description
Participants randomized to this arm will be invited to play the Tumaini game.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Participants randomized to this arm will receive no intervention beyond the current standard of care for sexual education.
Intervention Type
Behavioral
Intervention Name(s)
Tumaini Mobile Phone Game
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number Interested in Participating
Description
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.
Time Frame
Month 1
Title
Time to Recruitment of 60 Participants
Description
The number of days needed to recruit 60 participants.
Time Frame
Month 1
Title
Number of Participants Lost to Follow Up
Description
The number of participants who consented to participate but then later could not be reached prior to completing all study visits.
Time Frame
Duration of Study (Up to 4 Months)
Title
Number of Participants Completing the Study
Description
The number of participants who completed all study visits after providing consent are presented here.
Time Frame
Duration of Study (Up to 4 Months)
Title
Number of Phones Returned
Description
The phone retention rate (phones not lost during the intervention) was assessed by the number of phones returned at the end of the intervention.
Time Frame
Month 2
Title
Number Reporting Game Was Very Fun
Description
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.
Time Frame
Day 17 (post-intervention)
Title
Number Reporting the Game is Valuable
Description
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.
Time Frame
Day 17 (post-intervention)
Title
Number of Participants Feeling Very Safe
Description
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.
Time Frame
Day 17 (post-intervention)
Title
Number of Participants Playing the Game
Description
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 Frame
Day 17 (post-intervention)
Secondary Outcome Measure Information:
Title
Change in Knowledge
Description
Knowledge measures will be assessed via Yes/No survey questions and will address puberty, HIV, sexually transmitted infections (STIs), pregnancy, condoms, and alcohol and drugs. Knowledge was assessed with 15 items and responses are coded as 0 or 1. Total scores range from 0 to 15, with higher scores indicating increased knowledge. A positive value for the change from baseline score indicates an increase in knowledge from the baseline assessment.
Time Frame
Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
Title
Change in Self-Efficacy
Description
Self-efficacy was assessed via a 3-point Likert scale, and addressed self-efficacy to seek advice about puberty, sex, relationships; to communicate about protected sex; to reject peer, partner and adult pressure to engage in risk behaviors. Self-efficacy was assessed with 9 items which were scored as 0, 0.5 or 1. Total scores ranged from 0 to 9, with higher scores indicating increased self-efficacy. A positive value for the change from baseline score indicates an increase in self-efficacy since the baseline assessment.
Time Frame
Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
Title
Change in Risk Assessment
Description
Risk assessment was assessed via a 3-point Likert scale, and addressed perceived risk of certain risk situations/behaviors and of contracting HIV. Risk is assessed with 4 items and responses are coded as 0, 0.5 or 1. Total scores range from 0 to 4, with higher scores indicating increased risk assessment. A positive value for the change from baseline score indicates an increase in assessing risky situations as risky.
Time Frame
Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
Title
Change in Behavioral Intention
Description
Behavioral intention was assessed via Yes/No questions. The measure addressed intention to seek advice, to avoid risk situations, and to engage in health protective behaviors. Behavioral intention is assessed with 6 items that are scored as 0 or 1 and total scores range from 0 to 6. Higher scores in indicate more intention to partake in health protective behaviors and a positive value for the change from baseline score indicates a desirable change in intention.
Time Frame
Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
Title
Change in Future Orientation
Description
Future orientation was assessed via a single multiple-choice question (Yes/No/Maybe) and addressed perceived locus of control. Response is coded as 0, 0.5, or 1 and higher scores indicate greater understanding of future locus of control. A positive value for the change from baseline score indicates a desirable change in scores.
Time Frame
Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
Title
Change in Perceived Social Norms
Description
Perceived social norms were assessed via a 3-point Likert and addressed sex, gender, condoms, and HIV stigma. Social norms were assessed with 6 items that are scored as 0, 0.5, or 1. Total scores range from 0 to 6 with higher scores indicating perception of more desirable social norms. A positive value for the change from baseline scores indicates a desirable change.
Time Frame
Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
Title
Change in Attitudes
Description
Attitudes were assessed via 3-pt Likert survey questions relating to HIV stigma, condoms, sex, gender, and future orientation. Attitudes were assessed with 15 items and responses coded as 0, 0.5, or 1. Total scores ranged from 0 to 15, with higher scores indicating more desirable attitudes. A positive value for the change from baseline score indicates an increase in desirable attitudes.
Time Frame
Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate Winskell, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kenya Medical Research Institute
City
Kisumu
Country
Kenya

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30068501
Citation
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.
Results Reference
result
PubMed Identifier
30916661
Citation
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.
Results Reference
result
PubMed Identifier
31115348
Citation
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.
Results Reference
result

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A Mobile Phone Game to Prevent HIV Among Young Africans

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