HIV/AIDSMMNCT02627365
Motivation Matters Study
A study testing Individualized, interactive short messaging intervention in people with HIV/AIDS, run by University of Washington at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Individualized, interactive short messaging intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteKenya
- Study dates
- Jan 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Plans to move away in next 6 months
- Contraindication to ART
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motivation Matters! Randomized Clinical Trial of Theory Based SMS to Support Treatment as Prevention in High-Risk Women
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.
Read the 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).
- Conditions
- HIV/AIDS
- Being tested
- Individualized, interactive short messaging intervention
- Keywords
- ART, mobile messaging, behaviour, motivation
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized, interactive short messaging interventionBehavioural
An Individualized, interactive short messaging intervention reminding study participants to take antiretroviral medication and report any problems.
| Study group | Role | What they receive |
|---|---|---|
| Individualized, interactive SMS | Experimental | Individualized, interactive SMS intervention plus Standard care. Messages sent automatically using the Text-IT system. Receives: Behavioral: Individualized, interactive short messaging intervention |
| Standard care | No intervention | Standard care according to Kenyan guidelines, including clinic-based adherence education and counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma HIV-1 viral load
The plasma HIV-1 viral load will be compared between participants in the intervention and in the non-intervention arm.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nairobi, Kenya Medical Research Institute
- Responsible party
- Principal investigator, Scott McClelland, University of Washington
- Investigators
- R. Scott McClelland, M.D, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627365
- Sponsor's protocol ID
- STUDY00000394
- Acronym
- MM
- Status last verified
- Nov 2020
- First submitted
- 8 Dec 2015
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37158872Palmer 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.
PubMed 32779730
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivation Matters! Randomized Clinical Trial of Theory Based SMS to Support Treatment as Prevention in High-Risk Women
- ClinicalTrials.gov ID
- NCT02627365
- Acronym / sponsor ID
- MM / STUDY00000394
- Conditions
- HIV/AIDS
- Keywords
- ART, mobile messaging, behaviour, motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- University of Nairobi, Kenya Medical Research Institute
- Study start
- Jan 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized, interactive SMS | Experimental | Behavioral: Individualized, interactive short messaging interventionIndividualized, interactive SMS intervention plus Standard care. Messages sent automatically using the Text-IT system. |
| Standard care | No intervention | –Standard care according to Kenyan guidelines, including clinic-based adherence education and counseling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (2 listed)
- Plans to move away in next 6 months
- Contraindication to ART
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized, interactive short messaging interventionAn Individualized, interactive short messaging intervention reminding study participants to take antiretroviral medication and report any problems. | Behavioural | Individualized, interactive SMS |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Derived from this study: PubMed 37158872Aunon 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.
- Derived from this study: PubMed 32779730Palmer 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.
Related trials for HIV/AIDS
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
RecruitingPhase 2
Multiple Interventions With Distinct Anti-reservoir Activities in People on Antiretroviral Treatment
HIV - Human Immunodeficiency Virus
RecruitingPhase 2
CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
HSIL, High Grade Squamous Intraepithelial Lesion, HPV-Related Squamous Cell Carcinoma
Recruiting
Improving Engagement in HIV and Cancer Care in Zimbabwe
Cancer, HIV
RecruitingObservational study
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
HIV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. Scott McClelland, M.D, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized, interactive short messaging intervention in people with HIV/AIDS, run by University of Washington at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma HIV-1 viral load (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02627365, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.