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

The Lotto to Link Study: A Prospective, Interventional, Randomized Study of Conditional Incentives to Engage HIV-positive Men in HIV Care in KwaZulu-Natal, South Africa

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Incentives; ART
• Intervention / Treatment: Other: Optimized ART linkage package; Other: Conditional lottery incentive

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.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Kwa-Zulu Natal
    • Sweetwaters, Kwa-Zulu Natal, South Africa
      • HSRC Sweetwaters

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Exclusion Criteria:

• There are no separate exclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Optimized ART linkage package; Participants in this arm will receive a clinic referral card and text messages to support linkage to ART.	Other: Optimized ART linkage package; Optimized ART linkage package
Experimental: 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	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of men virally suppressed after 6 months	Conditional lottery incentives, above and beyond an optimized linkage package, will increase the uptake of clinic visits, ART initiation, and viral suppression among HIV-positive men not yet in care.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of men who have a positive alcohol or drug test	Men who currently use drugs, consume more than the recommended amount of alcohol on an ongoing basis, or report depression and anxiety are less likely to link to care, stay retained in care, and achieve virologic suppression.	6 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Ruanne V Barnabas, MD, University of Washington

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2017
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Actual): May 30, 2019
• Last Update Submitted That Met QC Criteria: May 28, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: STUDY00000036; 5R21MH110026 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No