Mobile Technology for HIV Prevention
(YouthHealth Trial)
Trial Summary
What is the purpose of this trial?
The goal of the project is to find out how the investigators can use mobile phones to prevent HIV and address related health problems such as sexual health and mental health among adolescents. The investigators will evaluate and adapt an existing text-message and interactive voice recognition (IVR) system. IVR is Interactive voice response is a technology that allows humans to interact with a computer-operated phone system through the use of voice and DTMF tones input via a keypad.The system was designed by FHI 360 (note FHI 360 is the name of the non-profit not an acronym). FHI 360 is an international nonprofit working to improve the health and well-being of people in the United States and around the world. FHI 360 staffs more than 4,000 professionals who work in more than 60 countries. Examples of the existing content is available (https://m4rh.fhi360.org/?page_id=191) and we have a letter of support from FHI 360, included in my funded grant proposal, stating we may use and modify this content as needed. As noted below anyone can access this content by dialing #161 when in Uganda. FHI 360 sexual reproductive health information is currently available across Uganda for free and can be accessed in by dialing #161.The proposed research comprises two phases. Phase 1 involves two steps, (A) "theater pretesting" (includes brief interviews) (B) focus groups (or more detailed interviews depending on COVID-19 guidelines and described in detail below) that will involve asking adolescents to discuss new messages that would provide basic information about pre-exposure prophylaxis (PrEP) as well as, a set of questions about mental health, and alcohol use. We will conduct focus groups with these adolescents and elicit responses to improve the acceptability of the messages (described in detail below).We will then modify any content as needed and conduct Phase 2 which involves (A) randomized control trial and (B) qualitative key informant interviews. Adolescents (N=200) will be randomly assigned to either the mobile phone-based intervention or to standard of care. Through this approach we will evaluate our adaptation of FHI 360's existing text message and interactive voice recognition (IVR). The adaptation will include PrEP information as well as specific mental health and hazardous alcohol use screens, promote HIV prevention for all adolescents, and support linkage to behavioral health counselors for symptomatic adolescents.
Eligibility Criteria
This trial is for adolescents aged 15-19 living in the greater Masaka region of southern Uganda who own a mobile phone and can consent to participate. They should not have taken part in Phase I of the study, ensuring new participants for Phase II.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: Theater Pretesting and Focus Groups
Theater pretesting involves developing the messages and concepts of an intervention and exploring them with intended audiences, followed by focus groups to gather feedback.
Phase 2: Randomized Control Trial
Participants are randomized into two arms to evaluate the mobile phone-based intervention versus standard of care.
Follow-up
Participants are monitored for outcomes such as HIV testing, mental health, and substance use.
Treatment Details
Interventions
- Youth Health SMS
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Who Is Running the Clinical Trial?
New York State Psychiatric Institute
Lead Sponsor
Washington University School of Medicine
Collaborator
National Institute of Mental Health (NIMH)
Collaborator