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OpenTrials
Completed

NCT Number: NCT03308097

A Mobile Intervention to Improve Uptake of PrEP for Southern Black MSM

This study will develop and test an interactive mobile messaging intervention to improve engagement in care related to Pre-exposure Prophylaxis (PrEP) and decrease HIV risk behaviors for Black men who have sex with men living in the Southern U.S. The mobile messaging intervention will include interactive text messaging and free, publicly available links to websites and YouTube videos. During the intervention participants will gain information about their health, improve motivation for engagement in PrEP related care, and build skills for healthy behaviors. Participants will also receive intervention materials to help decrease frequent barriers to care. If the intervention is found to be effective, it can be tested in a larger study and then disseminated.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

About this study

The uptake of Pre-Exposure Prophylaxis (PrEP) has been slow for young Black men who have sex with men (BMSM) living in the Southern United States. This is a significant issue because eight of the ten states with the highest rates of new HIV infections are located in the South. Jackson, Mississippi (MS) (the site of this project) has the second highest AIDS diagnosis rate in the nation, and the highest rate of HIV infection for young urban Black men who have sex with men. This study will develop and test an engaging, interactive, and cost effective mobile messaging intervention to improve linkage to PrEP care for BMSM (18-35 yrs) living in Jackson, MS. BMSM eligible for PrEP, receiving care at the University of Mississippi Medical Center sexually-transmitted infections (STI)/HIV testing clinics, will be texted interactive links to publicly available, online content about PrEP and HIV prevention. Links will be sent to PrEP eligible BMSM by 8-16 interactive text messages over 4 weeks. The material used in the intervention will be consistent with the Information Motivation Behavior (IMB) Model and will address cultural and structural barriers to initiating PrEP care. A small randomized controlled study among 66 new participants in the clinics will examine the preliminary efficacy of the intervention compared to enhanced standard of care on attendance at a PrEP Services Appointment (the first step in initiating PrEP care). It is hypothesized that, compared to BMSM receiving enhanced standard of care, BMSM receiving the PrEP Mobile Messaging Intervention will show greater attendance at a PrEP Services Appointment and decreased HIV risk behavior at 4 and 16 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English speaking
  • Black MSM
  • Eligible for PrEP
  • Visit STI/HIV testing clinics at University of Mississippi Medical Center
  • Able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment

Exclusion criteria

  • Involved in another PrEP or HIV prevention related study

Treatment and study plan

PrEP Mobile Messaging Intervention

Behavioral

See group description

Enhanced Standard of Care

Behavioral

See group description

Primary outcomes

  1. Number of PrEP Services Appointments Attended-Full Sample

    Time frame: 16 weeks

    With participant consent, staff at the STI/HIV testing clinic will abstract from the electronic medical record any PrEP Services Appointment, and any PrEP related care.

  2. Number of PrEP Services Appointments Attended- Restricted Sample

    Time frame: 16 weeks

    With participant consent, staff at the STI/HIV testing clinic will abstract from the electronic medical record any PrEP Services Appointment, and any PrEP related care.

    Restricted Sample is only those who did not receive a PrEP prescription the same day as enrollment.

  3. Number of Participants Who Received a PrEP Prescription-Full Sample

    Time frame: 16 weeks

    Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant.

  4. Number of Participants Who Received a PrEP Prescription-Restricted Sample

    Time frame: 16 weeks

    Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant.

    Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.

Secondary outcomes

  1. Change in PrEP Knowledge-Full Sample

    Time frame: Baseline, 16 weeks

    Change in participants score on the PrEP Knowledge Questionnaire between baseline and 16 weeks follow-up. Scores can range from 0-3, with higher scores indicating greater PrEP knowledge.

  2. Change in PrEP Knowledge-Restricted Sample

    Time frame: Baseline, 16 weeks

    Change in participants score on the PrEP Knowledge Questionnaire between baseline and 16 weeks follow-up. Scores can range from 0-3, with higher scores indicating greater PrEP knowledge.

    Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.

  3. Change in Social Motivational Readiness for PrEP Care-Full Sample

    Time frame: Baseline, 16 weeks

    Change in participants' score on the IMB PrEP Motivation Scale (to assess personal and social motivations for PrEP use) from baseline to16 weeks follow-up. Scores can range from 8 - 32, with higher scores indicating greater motivation.

  4. Change in Social Motivational Readiness for PrEP Care-Restricted Sample

    Time frame: Baseline, 16 weeks

    Change in participants' score on the IMB PrEP Motivation Scale (to assess personal and social motivations for PrEP use) from baseline to16 weeks follow-up. Scores can range from 8 - 32, with higher scores indicating greater motivation.

    Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.

  5. Change in PrEP Self-efficacy-Full Sample

    Time frame: Baseline, 16 weeks

    Change in participants' score on the IMB PrEP Behavioral Skills Scale between baseline and 16 weeks, which assesses self-efficacy for taking PrEP as prescribed and assesses self-efficacy for PrEP related medical appointments. Scores can range from 7 - 28, with higher scores indicating greater self-efficacy.

  6. Change in PrEP Self-efficacy-Restricted Sample

    Time frame: Baseline, 16 weeks

    Change in participants' score on the IMB PrEP Behavioral Skills Scale between baseline and 16 weeks, which assesses self-efficacy for taking PrEP as prescribed and assesses self-efficacy for PrEP related medical appointments. Scores can range from 7 - 28, with higher scores indicating greater self-efficacy.

    Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

  • University of Mississippi Medical Center

Registry information

Acronym: MobilePrEP

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 12, 2017
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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