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.
Lifelong antiretroviral therapy (ART) (Option B+) is recommended for all HIV-infected pregnant/postpartum women, but high adherence is required to maximize HIV prevention potential and maintain maternal health. Mobile health (mHealth) interventions may provide treatment adherence support for women during, and beyond, the pregnancy and postpartum periods.



We are conducting an unblinded, triple-arm randomized clinical trial (Mobile WACh X) of one-way short message service (SMS) vs. two-way SMS vs. control (no SMS) to improve maternal ART adherence and retention in care by 2years postpartum. We will enroll 825 women from Nairobi and Western Kenya. Women in the intervention arms receive weekly, semi-automated motivational and educational SMS and visit reminders via an interactive, human-computer hybrid communication system. Participants in the two-way SMS arm are also asked to respond to a question related to the message. SMS are based in behavioral theory, are tailored to participant characteristics through SMS tracks, and are timed along the pregnancy/postpartum continuum. After enrollment, follow-up visits are scheduled at 6weeks; 6, 12, 18, and 24months postpartum. The primary outcomes, virological failure (HIV viral load ≥1000copies/mL), maternal retention in care, and infant HIV infection or death, will be compared in an intent to treat analysis. We will also measure ART adherence and drug resistance.



Personalized and tailored SMS to support HIV-infected women during and after pregnancy may be an effective strategy to motivate women to adhere to ART and remain in care and improve maternal and infant outcomes.
Department of Global Health, University of Washington, Box 359909, Seattle, WA 98195-7236, USA. Electronic address: adrake2@uw.edu.
Alison L
AL
Drake
Departments of Global Health and Obstetrics and Gynecology, University of Washington, Box 359909, Seattle, WA 98195-7236, USA. Electronic address: junger@uw.edu.
Jennifer A
JA
Unger
Departments of Global Health and Epidemiology, University of Washington, Box 359909, Seattle, WA 98195-7236, USA. Electronic address: keshet@uw.edu.
Keshet
K
Ronen
Department of Research and Programs, Kenyatta National Hospital, PO Box 20723-00202, Nairobi, Kenya. Electronic address: daniel.matemo@gmail.com.
Daniel
D
Matemo
Department of Computer Science and Engineering, University of Washington, Box 352350, Seattle, WA 98195-7236, USA. Electronic address: tperrier@cs.washington.edu.
Trevor
T
Perrier
Department of Computer Science, University of Cape Town, Room 306, Computer Science Building, Cape Town, South Africa. Electronic address: bderenzi@cs.uct.ac.za.
Brian
B
DeRenzi
Department of Biostatistics, University of Washington, Box 359909, Seattle, WA 98195-7236, USA. Electronic address: barbrar@uw.edu.
Barbra A
BA
Richardson
Department of Research and Programs, Kenyatta National Hospital, PO Box 20723-00202, Nairobi, Kenya. Electronic address: kinuthia@uw.edu.
John
J
Kinuthia
Departments of Global Health, Medicine, Epidemiology, and Pediatrics, University of Washington, Box 359909, Seattle, WA 98195-7236, USA. Electronic address: gjohn@uw.edu.
Grace
G
John-Stewart
D019380:Anti-HIV Agents / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000517:prevention & control* / Q000635:transmission; D006801:Humans; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D007630:Kenya; D055118:Medication Adherence / Q000523:psychology; D010353:Patient Education as Topic / Q000379:methods; D017216:Telemedicine / Q000379:methods*; D060145:Text Messaging; D016896:Treatment Outcome
D019380:Anti-HIV Agents
Adherence; Antiretroviral therapy; Pregnancy; Prevention of mother-to-child HIV transmission; SMS; mHealth