Social Norms and Priming to Improve Adherence to Antiretroviral Therapy and Retention in Care

HIV Infection Clinical Trial

Official title:

Pilot Study of a Multi-Pronged Intervention Using Social Norms and Priming to Improve Adherence to Antiretroviral Therapy and Retention in Care Among Adults Living With HIV in Tanzania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938533
• Other study ID #: OPP1118511
• Status: Completed
• Phase: N/A
• First received: October 11, 2016
• Last updated: October 26, 2017
• Start date: August 2015
• Est. completion date: July 2016

Study information

• Verified date: October 2017
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Interventions incorporating constructs from behavioral economics and psychology have the potential to enhance HIV 'treatment as prevention' (TasP) strategies. To test this hypothesis, the investigators evaluated a combination intervention to improve antiretroviral therapy (ART) adherence based on the concepts of social norms and priming.

Description:

The investigators conducted a quasi-experimental pilot study of a combination behavioral intervention based on the concepts of social norms and priming. The intervention included visual feedback about clinic-level retention in care, a self-relevant prime, and useful take-home items with the priming image. The intervention was developed using tools from marketing research and patient-centered design. The hypothesis was that the intervention would improve retention in care and adherence to ART among patients living with HIV infection (PLHIV). The intervention was implemented at two HIV primary clinics in Shinyanga, Tanzania in 2-week intervals for six months. The investigators reviewed medical records of a random sample of exposed and unexposed adult PLHIV to compare retention and the proportion of patients with medication possession ratio (MPR) ≥95% after six months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. At least 18 years of age

2. Living with HIV infection

3. Receiving HIV primary care at one of the two study clinics

Related Conditions & MeSH terms

• Adherence
• HIV Infection
• HIV Infections

Intervention

Behavioral:
• Intervention
The intervention includes a clinic-based component and a take-home component. All components include the priming image of a Baobab tree. The clinic-based component is an interactive poster that rewarded appointment attendance. Patients who attend three consecutive on-time visits are congratulated and given a colored sticker to place on a poster that is publicly displayed at the clinic. In one clinic, the take-home component is a 2015 calendar in Kiswahili that contained the priming Baobab image. In the other clinic, the take-home component is a small plastic pillbox featuring the Baobab logo.

Locations

Country	Name	City	State
Tanzania	Bugsi Dispensary	Kahama	Shinyanga
Tanzania	Tinde Health Center	Shinyanga

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Berkeley	Mexican National Institute of Public Health, Ministry of Health, Tanzania

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention in care, defined as an attended visit between 150-210 days after the baseline visit	This measure of retention in care accounts for variability in visit scheduling by individual providers and therefore uses a window period of 150-210 days to determine whether the patient was in care at 6 months	6 months
Primary	>=95% medication possession ratio (MPR)	MPR is a measure of ART adherence that is correlated with viral suppression	6 months
Secondary	The proportion of scheduled visits that were completed during the 6-month observation period		6 months
Secondary	Medication possession ratio (MPR), continuous scale		6 months