IBIS Megastudy of Interventions to Encourage HIV Retesting

Official title

Transformative Approaches to Rapidly and Efficiently Test Demand Creation Interventions to Promote HIV Retesting in Adults at Increased Risk of HIV

Overview

In this study, the investigators will test the effectiveness of multiple low-cost behavioral interventions, designed with end-user input, to promote HIV retesting among adults in rural Kenya and Uganda who have higher risk of HIV exposure.

Detailed description

HIV re-testing is crucial in ensuring early identification of disease to promote well-being of an individual as well as preventing onward spread of infection. The IBIS megastudy of interventions to encourage HIV retesting aims to test up to 12 different strategies aimed at encouraging repeat testing of HIV among individuals \>/= 15 years old who are at increased risk of HIV infection. The different strategies are aimed at modifying individual behavior to enhance HIV testing. The study aims to enroll 30,000-40,000 individuals from 8 HIV testing sites in South West Uganda and Western Kenya. The study will then evaluate the effectiveness of the interventions by comparing HIV retesting rates 3-6 months later in the different study arms. The data collected during the study will further be used to understand which of the interventions offered worked best and for whom.

Interventions

• Behavioral Risk assessment messaging
  Participants will be shown a brief video message at their baseline visit, containing information related to HIV risk assessment core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at about 8 and 11 weeks after baseline reminding them about HIV retesting and re-emphasizing concepts from the HIV risk assessment content category.
• Behavioral U=U messaging
  Participants will be shown a brief video message at their baseline visit, containing information related to U=U core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at about 8 and 11 weeks after baseline reminding them about HIV retesting and re-emphasizing concepts from the U=U content category.
• Behavioral Community benefits messaging
  Participants will be shown a brief video message at their baseline visit, containing information related to Community Benefits core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at about 8 and 11 weeks after baseline reminding them about HIV retesting and re-emphasizing concepts from the Community Benefits content category.
• Behavioral Fresh start effect
  Participants will be shown a brief video message at their baseline visit, containing information related to Fresh Start core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at about 8 and 11 weeks after baseline reminding them about HIV retesting and re-emphasizing concepts from the Fresh start effect content category.
• Behavioral Education-based messaging
  Participants will be shown a brief video message at their baseline visit, containing information related to HIV education core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at about 8 and 11 weeks after baseline reminding them about HIV retesting and re-emphasizing concepts from the Education-based content category.
• Behavioral Default appointment messaging
  Participants will be shown a brief video message at their baseline visit, containing information related to Default Appointment core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at about 8 and 11 weeks after baseline reminding them about HIV retesting and re-emphasizing concepts from the Default Appointment content category.
• Behavioral Reserved for you messaging
  Participants will be shown a brief video message at their baseline visit, containing information related to the "Reserved for you" core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at about 8 and 11 weeks after baseline reminding them about HIV retesting and re-emphasizing concepts from the "Reserved for you" content category.
• Behavioral Social norms (default) messaging
  Participants will be shown a brief video message at their baseline visit, containing information related to Social Norms core concepts and encouraging them to return for a repeat HIV test. The video message will be delivered by the default avatar. They will also receive brief SMS follow-up messages at about 8 and 11 weeks after baseline reminding them about HIV retesting and re-emphasizing concepts from the Social Norms content category.
• Behavioral Social norms (varied) messaging
  Participants will be shown a brief video message at their baseline visit, containing information related to Social Norms core concepts and encouraging them to return for a repeat HIV test. The video message will be delivered by an avatar that approximately matches each participant's age and sex. They will also receive brief SMS follow-up messages at about 8 and 11 weeks after baseline reminding them about HIV retesting and re-emphasizing concepts from the Social Norms content category.
• Behavioral Goal-setting messaging
  Participants will be shown a brief video message at their baseline visit, containing information related to goal-setting core concepts and encouraging them to return for a repeat HIV test. They will also receive brief SMS follow-up messages at about 8 and 11 weeks after baseline reminding them about HIV retesting and re-emphasizing concepts from the goal-setting content category.

Primary outcome measures

• HIV retesting uptake [Time frame: Measured 3-6 months after baseline visit]

Secondary outcome measures (1)

• PrEP uptake at follow up [Time frame: 3-6 months]

Eligibility criteria

Inclusion criteria

• at least 15 years of age
• Accessing HIV testing services at study-associated hospitals or clinics
• At increased risk of HIV infection (defined by national (Kenya or Uganda) MoH criteria)
• Documented negative HIV antibody test at time of enrollment
• No intent to migrate out of community in next 3 months
• Daily access to a mobile phone (required since some of the interventions will be delivered by phone)

Exclusion criteria

• HIV-positive at time of enrollment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Screening

Study locations

Kenya · 1 center

• Kenya Medical Research Institution (KEMRI) — Mbita

Uganda · 1 center

• Infectious Diseases Research Collaboration (IDRC) — Mbarara

Publications

• Marson K, Kabami J, Buttenheim AM, Bennett D, Petersen ML, Havlir DV, Kamya MR, Ayieko J, Thirumurthy H, Chamie G. A megastudy of behavioral interventions to promote frequent HIV testing among adults at high risk of HIV infection in Kenya and Uganda: study protocol for a randomized controlled trial. Trials. 2026 May 21. doi: 10.1186/s13063-026-09783-4. Online ahead of print. PMID 42163283

Identifiers

NCT: NCT06971367 · 23-39197- 2 · R01MH132438

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗