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.

Drake AL ，Unger JA ，Ronen K ，Matemo D ，Perrier T ，DeRenzi B ，Richardson BA ，Kinuthia J ，John-Stewart G ... -  《-》

The effect of an interactive weekly mobile phone messaging on retention in prevention of mother to child transmission (PMTCT) of HIV program: study protocol for a randomized controlled trial (WELTEL PMTCT).

Awiti PO ，Grotta A ，van der Kop M ，Dusabe J ，Thorson A ，Mwangi J ，Belloco R ，Lester R ，Ternent L ，Were E ，Ekström AM ... -  《BMC Medical Informatics and Decision Making》

SMS messaging to improve retention and viral suppression in prevention of mother-to-child HIV transmission (PMTCT) programs in Kenya: A 3-arm randomized clinical trial.

Kinuthia J ，Ronen K ，Unger JA ，Jiang W ，Matemo D ，Perrier T ，Osborn L ，Chohan BH ，Drake AL ，Richardson BA ，John-Stewart G ... -  《-》

SMS messaging to improve ART adherence: perspectives of pregnant HIV-infected women in Kenya on HIV-related message content.

Ronen K ，Unger JA ，Drake AL ，Perrier T ，Akinyi P ，Osborn L ，Matemo D ，O'Malley G ，Kinuthia J ，John-Stewart G ... -  《-》

An Interactive Text Messaging Intervention to Improve Adherence to Option B+ Prevention of Mother-to-Child HIV Transmission in Kenya: Cost Analysis.

Mobile health (mHealth) approaches offer potentially affordable ways to support the care of HIV-infected patients in overstretched health care systems. However, only few studies have analyzed the costs associated with mHealth solutions for HIV care. The aim of this study was to estimate the total incremental costs and incremental cost per beneficiary of an interactive SMS text messaging support intervention within a clinical trial. The Mobile WAChX trial (NCT02400671) evaluates an interactive semiautomated SMS text messaging intervention to improve adherence to antiretroviral therapy and retention in care among peripartum women infected with HIV in Kenya to reduce the mother-to-child transmission of HIV. Women were randomized to receive one-way versus two-way SMS text messages. Messages were sent weekly, and these messages included motivational and educational content and visit reminders; two-way messaging enabled prompt consultation with the nurse as needed. Microcosting methods were used to collect resource-use data related to implementing the Mobile WAChX SMS text messaging intervention. At 2 sites (Nairobi and Western Kenya), we conducted semistructured interviews with health personnel to identify startup and recurrent activities by obtaining information on the personnel, supplies, and equipment. Data on expenditures and prices from project expense reports, administrative records, and published government salary data were included to estimate the total incremental costs. Using a public provider perspective, we estimated incremental unit costs per beneficiary and per contact during 2017. The weighted average annual incremental costs for the two-way SMS text messaging group were US $3725 per facility, US $62 per beneficiary, and US $0.85 per contact to reach 115 beneficiaries. For the one-way SMS text messaging group, the weighted average annual incremental costs were US $2542 per facility, US $41 per beneficiary, and US $0.66 per contact to reach 117 beneficiaries. The largest cost shares were for the personnel: 48.2% (US $1794/US $3725) in two-way and 32.4% (US $825/US $2542) in one-way SMS text messaging groups. Costs associated with software development and communication accounted for 29.9% (US $1872/US $6267) of the costs in both intervention arms (US $1042 vs US $830, respectively). Cost information for budgeting and financial planning is relevant for implementing mHealth interventions in national health plans. Given the proportion of costs related to systems development, it is likely that costs per beneficiary will decline with the scale-up of the interventions.

Chen Y ，Ronen K ，Matemo D ，Unger JA ，Kinuthia J ，John-Stewart G ，Levin C ... -  《JMIR mHealth and uHealth》