Lotto to Link Study: A Prospective, Interventional, Randomized Study of Conditional Incentives

NCT ID: NCT03808194

Last Updated: 2019-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-26
• Study Completion Date: 2019-01-31

Brief Summary

In this study the investigators will adapt and strengthen, test effectiveness, and explore implementation of conditional lottery incentive linkage strategies to engage men in HIV care and ART in KwaZulu-Natal, South Africa.

Detailed Description

Of the 2.6 million South Africans on antiretroviral therapy (ART)1 only a third are men, despite men making up 45% of HIV-positive persons.2 HIV-positive men are underrepresented throughout the HIV prevention and care continuum, being less likely to test, link to care, initiate ART, and more likely to be lost to follow-up. Few strategies have focused on men, and when they have they have not been successful. Even with community-based HIV testing, referral, text message reminders, and lay-counselor support (an optimized testing and linkage to care package), doctors are only able to achieve 60% linkage to HIV care and ART among men. HIV-positive men who are not in care are at risk for HIV-associated morbidity and mortality, and their HIV-negative partners are at risk of HIV acquisition. Innovative strategies are needed to motivate HIV-positive men to engage in care, and specifically to initiate and adhere to ART.

Introducing a gamble, the chance of winning a lottery, into linkage to HIV care interventions could make engagement in care more attractive to men. Men are often risk-takers and linking to care successfully is a gamble: start ART vs. risk no ART. A lottery incentive strategy has been successfully used to increase uptake of HIV prevention; in one recent example, lottery incentives, conditioned on being STI (sexually transmitted infection) negative, decreased HIV incidence by 60% among 'risk-loving' individuals in Lesotho, demonstrating one of the largest effects to date of a behavioral intervention for HIV prevention. Given this prevention success, the investigators hypothesize that lottery incentives have the potential to overcome both structural and behavioral factors for linking HIV positive men to care, addressing logistical challenges and risk preferences specific to men. For scale-up and implementation, the investigators need to sculpt the content of lottery incentive strategies as well as the approach to identify men not in care for whom lottery incentives are likely to work.

In this study the investigators will adapt and strengthen, test effectiveness, and explore implementation of conditional lottery incentive linkage strategies to engage men in HIV care and ART in KwaZulu-Natal, South Africa (the Lotto to Link Study). With the investigators experienced, multi-disciplinary team, the investigators have drawn on their previous successful community-based counseling and testing and linkage to prevention and care work to strengthen linkage strategies for HIV-positive ART eligible men who are not in care.

The investigators will do 1) qualitative interviews to inform the study design, 2) conduct an individual randomized study of conditional lottery incentives compared to an optimized linkage package for HIV-positive men, and 3) finally, estimate the costs associated with conditional incentives and retention in care.

Conditions

Incentives; HIV Infections; ART

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Optimized ART linkage package

Participants in this arm will receive a clinic referral card and text messages to support linkage to ART.

Group Type: ACTIVE_COMPARATOR

Optimized ART linkage package

Intervention Type: OTHER

Optimized ART linkage package

Conditional lottery incentive

Participants in this arm will receive a clinic referral card and text messages to support linkage to ART and will be entered into a lottery each time they meet the following conditions: visited the clinic by month 1, initiated treatment by month 3, and achieved viral suppression by month 6

Group Type: EXPERIMENTAL

Conditional lottery incentive

Intervention Type: OTHER

Participants in the lottery incentive arm must fulfill the following criteria to be entered into the lottery. Participants must visit the clinic by month 1, initiate ART by month 3 and achieve viral suppression by month 6. Participants in this arm will be eligible to win the lottery.

Interventions

Conditional lottery incentive

Participants in the lottery incentive arm must fulfill the following criteria to be entered into the lottery. Participants must visit the clinic by month 1, initiate ART by month 3 and achieve viral suppression by month 6. Participants in this arm will be eligible to win the lottery.

Intervention Type: OTHER

Optimized ART linkage package

Optimized ART linkage package

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Reside in the study community for the duration of follow-up
• Must be 18 years or older
• Able and willing to provide informed consent for study procedures
• HIV-positive men must be eligible for ART by national guidelines and not on ART
• Access to confidential text messaging

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Ruanne Barnabas

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruanne V Barnabas, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

HSRC Sweetwaters

Sweetwaters, KwaZulu-Natal, South Africa

Countries

South Africa

References

Barnabas RV, van Heerden A, McConnell M, Szpiro AA, Krows ML, Schaafsma TT, Ngubane T, Nxele RB, Joseph P, Baeten JM, Celum CL, van Rooyen H. Lottery incentives have short-term impact on ART initiation among men: results from a randomized pilot study. J Int AIDS Soc. 2020 Jun;23 Suppl 2(Suppl 2):e25519. doi: 10.1002/jia2.25519.

Reference Type: DERIVED

PMID: 32589342 (View on PubMed)

Other Identifiers

5R21MH110026

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00000036

Identifier Type: -

Identifier Source: org_study_id