NCT02938533

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
438

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
Last Updated

October 30, 2017

Status Verified

October 1, 2017

Enrollment Period

9 months

First QC Date

October 11, 2016

Last Update Submit

October 26, 2017

Conditions

HIV InfectionAdherence

Outcome Measures

Primary Outcomes (2)

  • 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

  • >=95% medication possession ratio (MPR)

    MPR is a measure of ART adherence that is correlated with viral suppression

    6 months

Secondary Outcomes (2)

  • The proportion of scheduled visits that were completed during the 6-month observation period

    6 months

  • Medication possession ratio (MPR), continuous scale

    6 months

Study Arms (2)

Standard of Care

NO INTERVENTION

Standard HIV primary care services available at HIV care and treatment clinics in Tanzania.

Behavioral Intervention Using Social Norms and Priming

EXPERIMENTAL

Patients in this arm may have been exposed to the behavioral intervention, which included the following components: 1) visual feedback about clinic-level retention in care through an interactive poster; 2) a self-relevant priming image that appeared on all components; and 3) a take-home item (i.e., pillbox or calendar) with the priming image.

Behavioral: Intervention

Interventions

InterventionBEHAVIORAL

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.

Behavioral Intervention Using Social Norms and Priming

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age
  • Living with HIV infection
  • Receiving HIV primary care at one of the two study clinics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bugsi Dispensary

Kahama, Shinyanga, Tanzania

Location

Tinde Health Center

Shinyanga, Tanzania

Location

Related Publications (1)

  • McCoy SI, Fahey C, Rao A, Kapologwe N, Njau PF, Bautista-Arredondo S. 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. PLoS One. 2017 May 9;12(5):e0177394. doi: 10.1371/journal.pone.0177394. eCollection 2017.

    PMID: 28486553DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Methods

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Sandra I McCoy, PhD

    University of California, Berkeley

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 19, 2016

Study Start

August 1, 2015

Primary Completion

May 1, 2016

Study Completion

July 1, 2016

Last Updated

October 30, 2017

Record last verified: 2017-10

Locations

TA(2)