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Motivation Matters Study (MM)

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ClinicalTrials.gov Identifier: NCT02627365
Recruitment Status : Completed
First Posted : December 10, 2015
Last Update Posted : November 3, 2020
Sponsor:
Collaborators:
University of Nairobi
Kenya Medical Research Institute
Information provided by (Responsible Party):
Scott McClelland, University of Washington

Brief Summary:
The study aims to develop and evaluate the efficacy and causal mechanisms of an interactive SMS intervention to optimize individual health and secondary HIV prevention benefits of ART in HIV-positive FSWs.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Individualized, interactive short messaging intervention Not Applicable

Detailed Description:

Antiretroviral therapy (ART) is highly effective at reducing the infectiousness of HIV-positive people, and is considered the cornerstone of all new HIV prevention approaches. A critical question is how to harness the potency of ART to reduce transmission from female sex workers (FSWs), a key population that has been central to HIV transmission in Africa for more than 25 years. In high prevalence countries like Kenya, FSWs represent about 1% of the population, yet contribute to one in seven (14%) new HIV infections. Targeting treatment as prevention (TasP) to FSWs could efficiently reduce HIV transmission on a population level. Effective TasP will require higher levels of ART adherence than those achieved in typical treatment programs. The rapid spread of mobile technology in Africa provides unique opportunities for mobile health (mHealth) interventions, which have been shown to be acceptable to providers and patients, and can improve ART adherence and suppression of plasma HIV viral load.

The ability of mobile (SMS) interventions to support ART adherence in key populations like FSWs and unique clinical scenarios such as TasP has yet to be evaluated. The investigators will answer these fundamental questions by addressing the following aims: 1) To use a qualitative rapid assessment and development approach to craft a theory-based, individualized, interactive SMS intervention, grounded in the Theory of Information, Motivation, and Behavior (IMB), to support ART adherence in HIV-positive FSWs, 2) To compare individualized, interactive SMS to standard care in achieving undetectable HIV VL 6 months post ART initiation in a randomized controlled trial (RCT) with 210 FSWs and 3) To administer an adaptation of the LifeWindows Information - Motivation - Behavioral Skills ART Adherence Questionnaire (LW-IMB-AAQ) to understand the mechanism of our SMS intervention's effect by comparing perceptions of support and motivation to adhere to ART in FSWs who received the intervention versus standard care.

Our overarching goal is to develop and evaluate the efficacy and causal mechanisms of an interactive SMS intervention to optimize individual health and secondary HIV prevention benefits of ART in HIV-positive FSWs. The aims of this project proceed sequentially from developmental (Aim 1) through implementation of the intervention (Aim 2) to evaluation of the fit with the behavioral model (Aim 3).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Motivation Matters! Randomized Clinical Trial of Theory Based SMS to Support Treatment as Prevention in High-Risk Women
Study Start Date : January 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Individualized, interactive SMS
Individualized, interactive SMS intervention plus Standard care. Messages sent automatically using the Text-IT system.
Behavioral: Individualized, interactive short messaging intervention
An Individualized, interactive short messaging intervention reminding study participants to take antiretroviral medication and report any problems.

No Intervention: Standard care
Standard care according to Kenyan guidelines, including clinic-based adherence education and counseling.



Primary Outcome Measures :
  1. Plasma HIV-1 viral load [ Time Frame: six months ]
    The plasma HIV-1 viral load will be compared between participants in the intervention and in the non-intervention arm.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • More than 18 years or emancipated minor
  • Has access to mobile phone
  • Self-identifying female sex worker
  • Willing to receive study SMS messages
  • HIV-positive (any WHO stage or CD4)
  • Able to read or have someone else read
  • ART naïve
  • Informed consent obtained and signed.

Exclusion Criteria:

  • Plans to move away in next 6 months
  • Contraindication to ART

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02627365


Locations
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Kenya
Women's Health Project, Mombasa
Mombasa, Kenya, 254
Sponsors and Collaborators
University of Washington
University of Nairobi
Kenya Medical Research Institute
Investigators
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Principal Investigator: R. Scott McClelland, M.D, MPH University of Washington
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Scott McClelland, Professor, Medicine, Epidemiology, and Global Health, University of Washington
ClinicalTrials.gov Identifier: NCT02627365    
Other Study ID Numbers: STUDY00000394
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Keywords provided by Scott McClelland, University of Washington:
ART
mobile messaging
behaviour
motivation
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases