Clinical trial NCT02400671: Mobile Strategies for Women's and Children's Health: Optimizing Adherence and Efficacy of PMTCT/ART
Official title: Evaluation of Mhealth Strategies to Optimize Adherence and Efficacy of PMTCT/ART
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: mHealth
PMTCT
Adherence, Medication
SMS
Maternal Health
HIV/AIDS
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: University of Nairobi
name: Kenyatta National Hospital
First posted: 2015-03-27
Enrollment: 825
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Maternal Virologic Failure
timeFrame: 2 years postpartum
measure: Retention in Care
timeFrame: Assessed at 24 months postpartum
measure: Loss to Follow-up
timeFrame: Assessed at 24 months postpartum
measure: Infant HIV-free Survival
timeFrame: 2 years postpartum
Secondary outcomes:
measure: Maternal ART Adherence
timeFrame: 2 years postpartum
measure: Maternal ART Resistance
timeFrame: 2 years postpartum
measure: Maternal Perceptions of Intervention and Care Received
timeFrame: 2 years postpartum
Other outcomes:
Locations:
city: Ahero
country: Kenya
facility: Ahero District Hospital
city: Bondo
country: Kenya
facility: Bondo District Hospital
city: Nairobi
country: Kenya
facility: Mathare City Council Clinic
city: Nairobi
country: Kenya
facility: Riruta Health Centre
city: Oyugis
country: Kenya
facility: Rachuonyo sub-County Hospital
city: Siaya
country: Kenya
facility: Siaya County Referral Hospital
Study officials:
affiliation: UW
name: Grace John-Stewart
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Osborn L, Ronen K, Larsen AM, Richardson B, Khasimwa B, Chohan B, Matemo D, Unger J, Drake AL, Kinuthia J, John-Stewart G. Antenatal depressive symptoms in Kenyan women living with HIV: contributions of recent HIV diagnosis, stigma, and partner violence. AIDS Care. 2022 Jan;34(1):69-77. doi: 10.1080/09540121.2021.1981216. Epub 2021 Sep 27.
citation: 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 retention and viral suppression in prevention of mother-to-child HIV transmission (PMTCT) programs in Kenya: A 3-arm randomized clinical trial. PLoS Med. 2021 May 24;18(5):e1003650. doi: 10.1371/journal.pmed.1003650. eCollection 2021 May.