Using Mobile Technology to Prevent HIV and Related Youth Health Problems

NCT05130151 | Suspended

• 2 other identifiers: 8183K01MH122319
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• HIV-AIDS Test

  Self-report and verified at local clinic number of HIV Tests

  6 month

Secondary Outcomes (5)

• Depression

  6 month

• Alcohol Use

  6 month

• PrEP Use

  6 month

• Anxiety

  6 month

• Mental Health Counseling

  6 month

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in this arm will receive the mobile phone-based intervention.

Behavioral: Youth Health SMS

Standard of care

NO INTERVENTION

Participants in this arm will receive only standard of care.

Interventions

Youth Health SMS BEHAVIORAL

The intervention is comprised of an automated two-way text messaging and interactive voice recognition service that provides sexual reproductive health (SRH) and HIV prevention information. The proposed intervention will add PrEP information and mental health and alcohol use screeners to the platform with the goal of promoting linkage to HIV clinics and to phone-based mental health counseling for symptomatic participants.

Intervention

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents (aged 15-19 years): Self-report during enrollment and confirmed by school personnel or local community leader.
• Residing in the greater Masaka region in southern Uganda: Self-report during enrollment and confirmed by school personnel or local community leader.
• Own a mobile phone: Self-report during enrollment and confirmed visually by project director or research assistant.
• People who have the cognitive capacity to consent: A potential participant will be included if the researcher conducting the consent process determines that the potential participant has the cognitive capacity to consent. This will be determined by through the review of the consent forms.
• For Phase II, did not participate. In Phase I: Review of study records.

You may not qualify if:

• People who are not aged 15-19 years: Self-report during enrollment and confirmed by school personnel or local community leader.
• People who do not reside in the greater Masaka region in southern Uganda: Self-report during enrollment and confirmed by school personnel or local community leader.
• People who do not own a mobile phone: Self-report during enrollment and confirmed visually by project director or research assistant.
• People who do not have the cognitive capacity to consent: A potential participant will be excluded if the researcher conducting the consent process determines that the potential participant has a mental deficit or does not have the cognitive capacity to understand the consent process and proposed research.
• Participants in phase 1 will be excluded from phase 2: Review of study records

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Washington University School of Medicine: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (7)

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Olsen PS, Plourde KF, Lasway C, van Praag E. Insights From a Text Messaging-Based Sexual and Reproductive Health Information Program in Tanzania (m4RH): Retrospective Analysis. JMIR Mhealth Uhealth. 2018 Nov 1;6(11):e10190. doi: 10.2196/10190.

  PMID: 30389651 BACKGROUND

• Bohn MJ, Babor TF, Kranzler HR. The Alcohol Use Disorders Identification Test (AUDIT): validation of a screening instrument for use in medical settings. J Stud Alcohol. 1995 Jul;56(4):423-32. doi: 10.15288/jsa.1995.56.423.

  PMID: 7674678 BACKGROUND

• Johnson D, Juras R, Riley P, Chatterji M, Sloane P, Choi SK, Johns B. A randomized controlled trial of the impact of a family planning mHealth service on knowledge and use of contraception. Contraception. 2017 Jan;95(1):90-97. doi: 10.1016/j.contraception.2016.07.009. Epub 2016 Jul 13.

  PMID: 27421767 BACKGROUND

• Vahdat HL, L'Engle KL, Plourde KF, Magaria L, Olawo A. There are some questions you may not ask in a clinic: providing contraception information to young people in Kenya using SMS. Int J Gynaecol Obstet. 2013 Nov;123 Suppl 1:e2-6. doi: 10.1016/j.ijgo.2013.07.009. Epub 2013 Aug 2.

  PMID: 24012514 BACKGROUND

• Kreniske P, Namuyaba OI, Kasumba R, Namatovu P, Ssewamala F, Wingood G, Wei Y, Ybarra ML, Oloya C, Tindyebwa C, Ntulo C, Mujune V, Chang LW, Mellins CA, Santelli JS. Mobile Phone Technology for Preventing HIV and Related Youth Health Problems, Sexual Health, Mental Health, and Substance Use Problems in Southwest Uganda (Youth Health SMS): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Dec 19;12:e49352. doi: 10.2196/49352.

  PMID: 38113102 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants and providers are the parties involved in the clinical trial who are prevented from having knowledge of the interventions assigned to individual participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: Adolescents (N = 200) will be randomized into two arms - 100 into the adapted mobile phone-based intervention arm, and 100 into standard education provided in schools.

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 22, 2021
• Study Start: August 9, 2023
• Primary Completion (Estimated): August 20, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: This will be provided no more than three months after the trial has been completed.
• Access Criteria: We will upload to clinicaltrials.gov

Locations

US (1)