Mobile Phone Technology for Prevention of Mother-to-Child Transmission of HIV: Acceptability, Effectiveness, and Cost
This study has been completed.
Sponsor:
Elizabeth Glaser Pediatric AIDS Foundation
Collaborators:
World Health Organization, Alliance for Health Policy and Systems Research
Kenya National AIDS & STI Control Programme
Information provided by (Responsible Party):
Elizabeth Glaser Pediatric AIDS Foundation
ClinicalTrials.gov Identifier:
NCT01645865
First received: July 18, 2012
Last updated: November 12, 2014
Last verified: November 2014
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Purpose
Although gains have been made in achieving the health-related Millennium Development Goals (MDG), much is still needed in countries affected by high levels of HIV/AIDS. Prevention of mother-to-child transmission (PMTCT) is a cornerstone strategy in reducing infant mortality from HIV. The study will employ a cluster randomized control trial (cRCT) with 26 health facilities randomized to two arms (intervention or control) to determine the effect of mobile phone technology on completion of key PMTCT milestones from antenatal to six weeks postpartum. The study will examine the acceptability, effectiveness, and cost of implementing a PMTCT-focused mHealth strategy among HIV-infected pregnant women, health workers, and male partners.
| Condition | Intervention |
|---|---|
|
HIV HIV Infections AIDS Antiretroviral Therapy |
Behavioral: Control Behavioral: Intervention |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Mobile Phone Technology for Prevention of Mother-to-Child Transmission of HIV: Acceptability, Effectiveness, and Cost |
Resource links provided by NLM:
Further study details as provided by Elizabeth Glaser Pediatric AIDS Foundation:
Primary Outcome Measures:
- The proportion of women who successfully complete key PMTCT transition points from antenatal to six weeks postpartum. [ Time Frame: ~ 6 months ] [ Designated as safety issue: No ]
- Initiation of Infant prophylaxis, Facility delivery and receipt of results of 6 weeks early infant diagnosis by DNA PCR [ Time Frame: ~ 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Uptake ARV prophylaxis/ART during labor, delivery, and postpartum [ Time Frame: ~ 6 months ] [ Designated as safety issue: No ]
- Self-reported maternal adherence to ARV prophylaxis/ART during pregnancy [ Time Frame: ~ 4 months ] [ Designated as safety issue: No ]
- Time to initiation of ARV prophylaxis/ART uptake after initial identification of HIV seropositivity within ANC [ Time Frame: ~ 1 month ] [ Designated as safety issue: No ]
| Enrollment: | 600 |
| Study Start Date: | May 2011 |
| Study Completion Date: | April 2014 |
| Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Control |
Behavioral: Control
Health facilities where PMTCT services are available in the traditional clinical setting with HIV testing and counseling, PMTCT support, and enrollment in care and treatment.
|
| Intervention |
Behavioral: Intervention
In addition to the 'Standard of Care', HIV-infected pregnant women and male partners within the PMTCT program are engaged in multi-directional mobile communication for PMTCT promotion with health care providers.
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Potential participants are recruited from participating study sites.
Criteria
Inclusion Criteria (female):
- HIV-positive pregnant women seeking ANC at a study site
- Up to 32 weeks gestation
- Own or have access to a mobile phone on which they can receive calls and SMS messages
Exclusion Criteria (female):
- HIV-positive pregnant women who have already initiated antiretroviral treatment
Inclusion Criteria (male):
- Referral by pregnant female partner
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01645865
Please refer to this study by its ClinicalTrials.gov identifier: NCT01645865
Locations
| Kenya | |
| Elizabeth Glaser Pediatric AIDS Foundation | |
| Nairobi, Kenya | |
Sponsors and Collaborators
Elizabeth Glaser Pediatric AIDS Foundation
World Health Organization, Alliance for Health Policy and Systems Research
Kenya National AIDS & STI Control Programme
Investigators
| Principal Investigator: | John Ong'ech, MBChB, MMed, MPH | Elizabeth Glaser Pediatric AIDS Foundation, UON/KNH |
| Principal Investigator: | Seble Kassaye, MD, MS | Elizabeth Glaser Pediatric AIDS Foundation |
More Information
| Responsible Party: | Elizabeth Glaser Pediatric AIDS Foundation |
| ClinicalTrials.gov Identifier: | NCT01645865 History of Changes |
| Other Study ID Numbers: | RPC441 |
| Study First Received: | July 18, 2012 |
| Last Updated: | November 12, 2014 |
| Health Authority: | United Nations: World Health Organization Kenya: Kenyatta National Hospital - University of Nairobi Ethical Review Committee |
Keywords provided by Elizabeth Glaser Pediatric AIDS Foundation:
|
HIV AIDS PMTCT Mobile Phone SMS |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on September 23, 2016