NCT03808194

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

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

October 26, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 3, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 17, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

1.1 years

First QC Date

January 3, 2019

Last Update Submit

May 28, 2019

Conditions

IncentivesHIV InfectionsART

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of men who have a positive alcohol or drug test

    6 months

Study Arms (2)

Optimized ART linkage package

ACTIVE COMPARATOR

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

Other: Optimized ART linkage package

Conditional lottery incentive

EXPERIMENTAL

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

Interventions

Conditional lottery incentiveOTHER

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.

Conditional lottery incentive
Optimized ART linkage packageOTHER

Optimized ART linkage package

Optimized ART linkage package

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HSRC Sweetwaters

Sweetwaters, KwaZulu-Natal, South Africa

Location

Related Publications (1)

  • 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.

    PMID: 32589342DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ruanne V Barnabas, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: HIV-positive men who meet the study eligibility criteria will be randomized to one of two study arms: 1) Optimized ART linkage package, or 2) Optimized ART linkage package + conditional lottery incentive.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 17, 2019

Study Start

October 26, 2017

Primary Completion

November 30, 2018

Study Completion

January 31, 2019

Last Updated

May 30, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)