A Mobile Phone Game to Prevent HIV Among Young Africans

HIV/AIDS Clinical Trial

Official title:

A Mobile Phone Game to Prevent HIV Among Young Africans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03054051
• Other study ID #: IRB00081150
• Secondary ID: 5R34MH106368
• Status: Completed
• Phase: N/A
• Start date: March 20, 2017
• Est. completion date: June 19, 2017

Study information

• Verified date: September 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 19, 2017
• Est. primary completion date: June 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV/AIDS

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Kenya	Kenya Medical Research Institute	Kisumu

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	Kenya Medical Research Institute, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Kenya, 

References & Publications (3)

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: 10.2196/1120 — View 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. J — View 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. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Time to Recruitment of 60 Participants	The number of days needed to recruit 60 participants.	Month 1
Primary	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)
Primary	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)
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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	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.	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
Secondary	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.	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
Secondary	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.	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
Secondary	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.	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
Secondary	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.	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
Secondary	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.	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
Secondary	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.	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention