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

NCT01433185 | Completed

• 1 other identifier: 41186-E/G
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

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

Keywords

PMTCT; SMS; HIV Infections; Acquired Immunodeficiency Syndrome; Prevention & Control; Patient Compliance; Cellular Phone; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Proportion of women who attend postnatal clinic within 6-8 weeks postpartum

  6-8 weeks after delivery

• Proportion of infants tested for HIV by DNA PCR

  6-8 weeks after delivery

Secondary Outcomes (3)

• Infant adherence to antiretroviral prophylaxis

  Up to 6 weeks after delivery

• Time to post-natal clinic return

  Up to 8 weeks after delivery

• Maternal adherence to antiretroviral prophylaxis

  Up to 8 weeks after delivery

Study Arms (2)

Text message (SMS)

EXPERIMENTAL

Text messages sent to women before and after delivery

Other: Text message

Usual care (current standard of care)

NO INTERVENTION

Current standard of care for women enrolled in PMTCT programs

Interventions

Text message OTHER

Text messages sent to women before and after delivery

Also known as: SMS, short message service, text messaging

Text message (SMS)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Kenya Medical Research Institute: collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

Kenya Medical Research Institute, Family AIDS Care and Education Services

Kisumu, Nyanza, Kenya

Location

Related Publications (2)

• 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.

  PMID: 25313586 RESULT

• 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.

  PMID: 25181408 RESULT

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Patient Compliance

Interventions

Spermine Synthase

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes

Study Officials

• Thomas A Odeny, MBChB, MPH

  University of Washington/Kenya Medical Research Institute

  PRINCIPAL INVESTIGATOR

• R Scott McClelland, MD, MPH

  University of Washington

  STUDY CHAIR

• Craig R Cohen, MD, MPH

  University of California, San Francisco

  STUDY CHAIR

• Carol Camlin, PhD

  University of California, San Francisco

  STUDY CHAIR

• Elizabeth A Bukusi, MBChB, MMed, MPH, PhD

  Kenya Medical Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2011
• First Posted: September 13, 2011
• Study Start: April 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 21, 2015

Record last verified: 2015-01

Locations

KE (1)