Clinical trial NCT01433185: Improving Uptake of Early Infant Diagnosis of HIV for the Prevention of Mother-to-child Transmission of HIV
Official title: Improving Uptake of Early Infant Diagnosis of HIV for PMTCT: a Randomized Trial of a Text Messaging Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Acquired Immunodeficiency Syndrome
Keywords: PMTCT
SMS
HIV Infections
Acquired Immunodeficiency Syndrome
Prevention & Control
Patient Compliance
Cellular Phone
Randomized Controlled Trial
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: University of California, San Francisco
First posted: 2011-09-13
Enrollment: 388
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Early accurate diagnosis is one of the first crucial steps in care for infants born to HIV-infected mothers. Early initiation of antiretroviral therapy (ART) relies upon early diagnosis and results in significant reductions in infant morbidity and mortality. There is little information on evidence-based interventions that specifically target improved attendance of postpartum clinic visits and subsequent infant HIV testing in the context of prevention of mother-to-child transmission of HIV (PMTCT) programs. The investigators propose a randomized controlled trial to examine the effect of text messages sent to women enrolled in PMTCT programs on adherence to postpartum clinic visits and uptake of early infant diagnosis by DNA polymerase chain reaction (PCR). This study seeks to test the hypotheses that (a) text messages sent to women enrolled in PMTCT will improve their attendance at the postnatal clinic within the first 6-8 weeks after childbirth; and (b) text messages sent to women enrolled in PMTCT programs will increase uptake of DNA PCR HIV testing at 6-8 weeks among infants exposed to HIV. This study will evaluate a novel strategy to improve adherence to postnatal clinic visits and increase the uptake of infant HIV testing. If proven superior to standard care, the proposed intervention can be easily scaled-up and integrated into existing healthcare systems in resource-limited settings. Findings from this study will provide randomized trial evidence to inform HIV prevention program planners and implementers. This study will also provide further information on the feasibility of using mobile phone-based technology for public health interventions in resource-limited settings.


Eligibility criteria: Inclusion Criteria:

* age at least 18 years
* report ability to read SMS
* ≥ 28 weeks gestation or delivery at study clinic on day of enrollment
* HIV positive women enrolled in the PMTCT program
* have access to a mobile phone (personal or partner's if HIV serostatus disclosed to partner)
* willing to receive SMS messages from the study
* planning to remain in the study area (Nyanza province) for the duration of the study

Exclusion Criteria:

* age less than 18 years old
* women who share phones with partners but HIV status not disclosed to partners
* intention to deliver at a non-study hospital

Primary outcomes:
measure: Proportion of women who attend postnatal clinic within 6-8 weeks postpartum
timeFrame: 6-8 weeks after delivery
measure: Proportion of infants tested for HIV by DNA PCR
timeFrame: 6-8 weeks after delivery
Secondary outcomes:
measure: Infant adherence to antiretroviral prophylaxis
timeFrame: Up to 6 weeks after delivery
measure: Time to post-natal clinic return
timeFrame: Up to 8 weeks after delivery
measure: Maternal adherence to antiretroviral prophylaxis
timeFrame: Up to 8 weeks after delivery
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute, Family AIDS Care and Education Services
state: Nyanza
Study officials:
affiliation: University of Washington/Kenya Medical Research Institute
name: Thomas A Odeny, MBChB, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: R Scott McClelland, MD, MPH
role: STUDY_CHAIR
affiliation: University of California, San Francisco
name: Craig R Cohen, MD, MPH
role: STUDY_CHAIR
affiliation: University of California, San Francisco
name: Carol Camlin, PhD
role: STUDY_CHAIR
affiliation: Kenya Medical Research Institute
name: Elizabeth A Bukusi, MBChB, MMed, MPH, PhD
role: STUDY_CHAIR
References:
citation: Odeny TA, Bukusi EA, Cohen CR, Yuhas K, Camlin CS, McClelland RS. Texting improves testing: a randomized trial of two-way SMS to increase postpartum prevention of mother-to-child transmission retention and infant HIV testing. AIDS. 2014 Sep 24;28(15):2307-12. doi: 10.1097/QAD.0000000000000409.
citation: Odeny TA, Newman M, Bukusi EA, McClelland RS, Cohen CR, Camlin CS. Developing content for a mHealth intervention to promote postpartum retention in prevention of mother-to-child HIV transmission programs and early infant diagnosis of HIV: a qualitative study. PLoS One. 2014 Sep 2;9(9):e106383. doi: 10.1371/journal.pone.0106383. eCollection 2014.