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Motivation Matters Study

NCT ID: NCT02627365

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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HIV/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Individualized, interactive SMS

Individualized, interactive SMS intervention plus Standard care. Messages sent automatically using the Text-IT system.

Group Type EXPERIMENTAL

Individualized, interactive short messaging intervention

Intervention Type BEHAVIORAL

An Individualized, interactive short messaging intervention reminding study participants to take antiretroviral medication and report any problems.

Standard care

Standard care according to Kenyan guidelines, including clinic-based adherence education and counseling.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Individualized, interactive short messaging intervention

An Individualized, interactive short messaging intervention reminding study participants to take antiretroviral medication and report any problems.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Nairobi

OTHER

Sponsor Role collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Scott McClelland

Professor, Medicine, Epidemiology, and Global Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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R. Scott McClelland, M.D, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Women's Health Project, Mombasa

Mombasa, , Kenya

Site Status

Countries

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Kenya

References

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Aunon FM, Wanje G, Richardson BA, Masese L, Odeny TA, Kinuthia J, Mandaliya K, Jaoko W, Simoni JM, McClelland RS. Randomized controlled trial of a theory-informed mHealth intervention to support ART adherence and viral suppression among women with HIV in Mombasa, Kenya: preliminary efficacy and participant-level feasibility and acceptability. BMC Public Health. 2023 May 8;23(1):837. doi: 10.1186/s12889-023-15638-3.

Reference Type DERIVED
PMID: 37158872 (View on PubMed)

Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.

Reference Type DERIVED
PMID: 32779730 (View on PubMed)

Other Identifiers

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STUDY00000394

Identifier Type: -

Identifier Source: org_study_id