Improving Uptake of Early Infant Diagnosis of HIV for the Prevention of Mother-to-child Transmission of HIV

NCT ID: NCT01433185

Last Updated: 2015-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 388 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-07-31

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.

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Text message (SMS)

Text messages sent to women before and after delivery

Group Type: EXPERIMENTAL

Text message

Intervention Type: OTHER

Text messages sent to women before and after delivery

Usual care (current standard of care)

Current standard of care for women enrolled in PMTCT programs

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Text message

Text messages sent to women before and after delivery

Intervention Type: OTHER

Other Intervention Names

SMS, short message service, text messaging

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kenya Medical Research Institute

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Thomas Odeny

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas A Odeny, MBChB, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington/Kenya Medical Research Institute

R Scott McClelland, MD, MPH

Role: STUDY_CHAIR

University of Washington

Craig R Cohen, MD, MPH

Role: STUDY_CHAIR

University of California, San Francisco

Carol Camlin, PhD

Role: STUDY_CHAIR

University of California, San Francisco

Elizabeth A Bukusi, MBChB, MMed, MPH, PhD

Role: STUDY_CHAIR

Kenya Medical Research Institute

Locations

Kenya Medical Research Institute, Family AIDS Care and Education Services

Kisumu, Nyanza, Kenya

Countries

Kenya

References

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.

Reference Type: RESULT

PMID: 25313586 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25181408 (View on PubMed)

Other Identifiers

41186-E/G

Identifier Type: -

Identifier Source: org_study_id