Mobile WAChx: Mobile Strategies for Women's and Children's Health: Optimizing Adherence and Efficacy of PMTCT/ART
Study Details
Study Description
Brief Summary
The investigators are conducting a 3-arm randomized trial comparing the effects of unidirectional SMS (ie: "push" messaging to participant) vs. bidirectional SMS dialogue between participant and provider vs. control (no SMS) among HIV-infected Kenyan mothers in Kenyan PMTCT-ART for outcomes of ART adherence and retention in care.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The investigators will compare trial arms for impact on maternal retention, adherence, virologic failure and resistance and infant HIV or HIV-free survival.
The investigators will determine correlates of maternal loss to follow-up and virologic failure and correlates of infant HIV in the overall study and stratified by trial arm. In the bidirectional SMS arm, the investigators will determine the rate of SMS interactivity, impact of critical time-points on messaging, and characteristics of high and low 'interactors'.
The investigators will determine cost-effectiveness of unidirectional and bidirectional SMS interventions. These data will contribute a potential scale-able strategy to improve PMTCT-ART as programs aspire to 'virtual elimination' of infant HIV.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Two-way SMS Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse |
Behavioral: SMS messaging
|
| Experimental: One-Way SMS Participants will receive weekly push SMS messaging |
Behavioral: SMS messaging
|
| No Intervention: Control Participants will receive standard of care (no intervention) |
Outcome Measures
Primary Outcome Measures
- Maternal virologic failure [2 years postpartum]
Prevalence of virologic failure (HIV RNA ≥1000 c/ml) after the first 4 months post-ART will be compared between study arms using Generalized Estimating Equations (GEE) with log-binomial link.
- Retention in care [2 years postpartum]
Timely clinic visit attendance during follow-up from enrollment in pregnancy to 12 and 24 months postpartum will be compared between study arms using GEE with log-binomial link.
- Loss to follow-up [2 years postpartum]
The proportions of women lost to follow-up at 12 and 24 months postpartum will be compared between study arms by log-binomial regression.
- Infant HIV-free survival [2 years postpartum]
Incidence of infant HIV acquisition or death will be compared between study arms using Cox proportional hazards regression.
Secondary Outcome Measures
- Maternal ART adherence [2 years postpartum]
ART adherence, defined as the proportion of days "covered" by ART between pharmacy refills, will be dichotomized and compared between arms using GEE with log-binomial link.
- Maternal ART resistance [2 years postpartum]
Incidence of drug resistance on ART will be compared between study arms using Cox proportional hazards regression.
- Maternal perceptions of intervention and care received [2 years postpartum]
Qualitative interviews at exit
Eligibility Criteria
Criteria
Inclusion Criteria:
- pregnant, HIV-infected, access to a mobile phone, remaining in study area for two years
Exclusion Criteria:
- enrolled in another research study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ahero District Hospital | Ahero | Kenya | ||
| 2 | Bondo District Hospital | Bondo | Kenya | ||
| 3 | Mathare City Council Clinic | Nairobi | Kenya | ||
| 4 | Riruta Health Centre | Nairobi | Kenya | ||
| 5 | Rachuonyo sub-County Hospital | Oyugis | Kenya | ||
| 6 | Siaya County Referral Hospital | Siaya | Kenya |
Sponsors and Collaborators
- University of Washington
- University of Nairobi
- Kenyatta National Hospital
Investigators
- Principal Investigator: Grace John-Stewart, UW
Study Documents (Full-Text)
None provided.More Information
Publications
- Drake AL, Unger JA, Ronen K, Matemo D, Perrier T, DeRenzi B, Richardson BA, Kinuthia J, John-Stewart G. Evaluation of mHealth strategies to optimize adherence and efficacy of Option B+ prevention of mother-to-child HIV transmission: Rationale, design and methods of a 3-armed randomized controlled trial. Contemp Clin Trials. 2017 Jun;57:44-50. doi: 10.1016/j.cct.2017.03.007. Epub 2017 Mar 14.
- Fairbanks J, Beima-Sofie K, Akinyi P, Matemo D, Unger JA, Kinuthia J, O'Malley G, Drake AL, John-Stewart G, Ronen K. You Will Know That Despite Being HIV Positive You Are Not Alone: Qualitative Study to Inform Content of a Text Messaging Intervention to Improve Prevention of Mother-to-Child HIV Transmission. JMIR Mhealth Uhealth. 2018 Jul 19;6(7):e10671. doi: 10.2196/10671.
- Lewis K, Harrington EK, Matemo D, Drake AL, Ronen K, O'Malley G, Kinuthia J, John-Stewart G, Unger JA. Utilizing perspectives from HIV-infected women, male partners and healthcare providers to design family planning SMS in Kenya: a qualitative study. BMC Health Serv Res. 2019 Nov 21;19(1):870. doi: 10.1186/s12913-019-4708-7.
- Ronen K, Unger JA, Drake AL, Perrier T, Akinyi P, Osborn L, Matemo D, O'Malley G, Kinuthia J, John-Stewart G. SMS messaging to improve ART adherence: perspectives of pregnant HIV-infected women in Kenya on HIV-related message content. AIDS Care. 2018 Apr;30(4):500-505. doi: 10.1080/09540121.2017.1417971. Epub 2017 Dec 18.
- STUDY00000916