NCT05378607: GOALS

Goals for Adherence with Low-cost Incentives

Active, enrolled NA Last updated 27 March 2025

What this trial tests

NA trial testing Incentivization based on gradually increasing, externally chosen adherence goals in ART in 560 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

18 April 2022

Primary endpoint
11 February 2027

11 August 2027

Quick facts

Lead sponsor	RAND
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	560
Start date	18 April 2022
Primary completion	11 February 2027
Estimated completion	11 August 2027
Sites	1 location across Uganda

Drugs / interventions tested

• Incentivization based on gradually increasing, externally chosen adherence goals
• End of year 1 adherence prize drawing
• SMS motivational messages + reminder of prize drawing
• Year 2 re-allocation based on year 1 performance
• End of Year 2 viral suppression prize drawing
• Incentivization based on gradually increasing self-chosen adherence goals
• Incentivization based on a fixed adherence goal
• SMS motivational messages

Conditions studied

• ART — all drugs for ART →
• HIV — all drugs for HIV →

Sponsor

RAND — full company profile →

Who can join

Adults 15 to 30, any sex, with ART or HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

GOALS is a three-year randomized control trial (RCT) aimed at testing the effectiveness of three incentive designs to improve the ART adherence of those in need of adherence support. Participants in the first treatment group (T1, n=140) will be eligible for a prize drawing every three months if they reach the adherence target set for them by the study team, gradually increasing from their baseline adherence towards 90% by the end of the year. Participants in the second treatment group (T2, n=140) will be eligible if they reach the adherence target they set for themselves (subject to reaching 90% at the end of year 1 and each target being at least as high as the previous one). Participants in the third treatment group will have a fixed adherence target of 90% and will be eligible for a prize drawing every three months if this target is reached. All treatment groups will receive weekly motivational messages and a reminder of the upcoming prize drawing. The control group (T4, n=140) will receive the usual standard of care offered by the hospital and weekly motivational messages. Primary outcomes measured using Wisepill devices are mean ART adherence and the fraction of clients with adherence of 90% or more. Secondary outcomes are viral suppression, the fraction of clients with treatment interruptions of 48hrs or more, and retention in care.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Goals for Adherence with Low-cost Incentives (GOALS): a protocol for a randomized controlled trial evaluating the impact of small airtime incentives on ART adherence among young people living with HIV in Kampala, Uganda.
   Linnemayr S, Huang HC, Wagner Z, Onkundi FK, et al · · 2023 · PMID 37559069 · DOI 10.1186/s13063-023-07449-z
2. Goals for Adherence with Low-cost Incentives (GOALS): A protocol for a randomized controlled trial in Kampala, Uganda
   Huang H, Linnemayr S, Wagner Z, Mukasa B, et al · · 2023 · DOI 10.21203/rs.3.rs-2625044/v1