Clinical trial NCT01579214: Cell Phone Messaging to Improve Communication of Critical Laboratory Results to Patients in Rural Uganda
Official title: Cell Phone Messaging to Improve Communication of Critical Laboratory Results to Patients in Rural Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Tuberculosis
Keywords: HIV
Africa south of the sahara
Knowledge of results
Communication barriers
Cellular Phones
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Mbarara University of Science and Technology
name: Fogarty International Center of the National Institute of Health
name: Harvard University
First posted: 2012-04-17
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a quasi-experimental design study with two periods of study. The pre-intervention period serves as the control group. During the intervention period, participants received one of three message types to be informed of their test results: 1) a standard message informing their abnormal result, 2) the standard message protected by a PIN number code, and 3) a coded texted message "ABCDEFG."

For our a priori hypotheses about the effect of receiving an SMS message on outcomes, we compared results for participants in the pre-intervention period with all those in the post-intervention period. This was a non-randomized intervention.

For our primary outcome (time to ART initiation) we assessed all participants with abnormal CD4 count results who were ART-naive at study enrollment. For our secondary outcome (time to clinic return) we looked at all study participants with abnormal CD4 counts.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Participants Initiating Antiretroviral Therapy (ART) Within 28 Days of Abnormal Result
timeFrame: 28 days
Secondary outcomes:
measure: Clinic Return Within 28 Days of Abnormal CD4 Count Result
timeFrame: 28 days
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: ISS Clinic, Mbarara Regional Referral Hospital
Study officials:
affiliation: Massachusetts General Hospital
name: Mark Siedner, MD MPH
role: STUDY_DIRECTOR
affiliation: Mbarara University of Science and Technology
name: Bosco Bwana, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital Center for Global Health
name: David R Bangsberg, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital Center for Global Health
name: Jessica Haberer, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siedner MJ, Haberer JE, Bwana MB, Ware NC, Bangsberg DR. High acceptability for cell phone text messages to improve communication of laboratory results with HIV-infected patients in rural Uganda: a cross-sectional survey study. BMC Med Inform Decis Mak. 2012 Jun 21;12:56. doi: 10.1186/1472-6947-12-56.
citation: Siedner MJ, Santorino D, Lankowski AJ, Kanyesigye M, Bwana MB, Haberer JE, Bangsberg DR. A combination SMS and transportation reimbursement intervention to improve HIV care following abnormal CD4 test results in rural Uganda: a prospective observational cohort study. BMC Med. 2015 Jul 6;13:160. doi: 10.1186/s12916-015-0397-1.
citation: Siedner MJ, Santorino D, Haberer JE, Bangsberg DR. Know your audience: predictors of success for a patient-centered texting app to augment linkage to HIV care in rural Uganda. J Med Internet Res. 2015 Mar 24;17(3):e78. doi: 10.2196/jmir.3859.