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Suspended Not applicable Interventional Accepts healthy volunteers

Using Mobile Technology to Prevent HIV and Related Youth Health Problems

ClinicalTrials.gov ID: NCT05130151

Public ClinicalTrials.gov record NCT05130151. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Using Mobile Technology to Prevent HIV and Related Youth Health Problems: Sexual Health, Mental Health and Substance Use in Southwest Uganda

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Since the start of this study I have moved from NYSPI to City University of New York. The study is currently paused. 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.

Study identification

NCT ID
NCT05130151
Recruitment status
Suspended
Study type
Interventional
Phase
Not applicable
Enrollment
200 participants

Conditions and interventions

Conditions

Interventions

Behavioral

Eligibility (public fields only)

Age range
15 Years to 19 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 8, 2023
Primary completion
Aug 19, 2027
Completion
Aug 31, 2028
Last update posted
Jan 8, 2026

2023 – 2028

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
New York State Psychiatric Institute New York New York 10032

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05130151, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 8, 2026 · Synced Sep 9, 2026

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