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Completed

NCT Number: NCT01579214

Cell Phone Messaging to Improve Communication of Critical Laboratory Results to Patients in Rural Uganda

The investigators will study the efficacy of a novel cellular phone messaging system to communicate health information and facilitate early return to clinic after abnormal laboratory results in rural Uganda.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ISS Clinic, Mbarara Regional Referral Hospital

Mbarara, Uganda

About this study

Among the challenges that complicate optimal health care delivery in rural settings is lack of communication between care providers and patients. Communication of abnormal laboratory results represents a particular challenge. Laboratory and other test results are often not reported until repeat visits weeks to months later. In the case of treatment failure, severe treatment complications, or evidence of opportunistic infection, such reporting delays likely result in adverse outcomes and potentially compromise future treatment options. The investigators propose to evaluate a novel strategy of communication using SMS text messaging to facilitate patient return to an HIV clinic in Uganda after critical laboratory results.

The investigators will consent and enroll participants at the time of laboratory testing for cluster of differentiation 4 (CD4) count, viral loads, acid fast bacteria smears of sputum, among others. Those with abnormal results will be randomized to various messaging formats and receive text messages requesting a prompt return to clinic. For outcomes, the investigators will measure successful receipt and comprehension of messages, as well as proportion returning within 14 days of the abnormal laboratory test.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV positive
  • Active in care at Mbarara Regional Referral Hospital HIV Clinic
  • Undergoing laboratory testing
  • Self-reported cell phone access
  • Agrees to participation and gives informed consent

Exclusion criteria

  • Age < 18
  • Resides outside great Mbarara area (Mbarara, Isingiro, Kyruhuura, Ibanda, or Ntungamo districts)

Treatment and study plan

Cellular Phone Text Messages

Other

Cellular phone text message formats to be sent to participants after abnormal laboratory results to communicate information and request early return to clinic.

Primary outcomes

  1. Participants Initiating Antiretroviral Therapy (ART) Within 28 Days of Abnormal Result

    Time frame: 28 days

    Number of Antiretroviral Therapy (ART) naive participants (subgroup of the sample) who initiated ART within 28 days of receiving abnormal result

Secondary outcomes

  1. Clinic Return Within 28 Days of Abnormal CD4 Count Result

    Time frame: 28 days

    Number of participants who returned to clinic within 28 days of abnormal CD4 count result

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Fogarty International Center of the National Institute of Health
  • Harvard University
  • Mbarara University of Science and Technology

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Apr 17, 2012
Registry last updated
Jan 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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