Interrupting HIV and TB Stigma in the Household in Uganda

NCT05124665 | Completed Results

• 3 other identifiers: 1R21TW0112701R21TW011270-012000024852
• Study Type: interventional
• Target: 612
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will carry out a prospective, household cluster-randomized, implementation trial evaluating a complex, multi-component, social and behavioral intervention designed to normalize the acceptance of HIV testing in the household and increase diagnosis of HIV.

Conditions

Hiv; Tuberculosis; Social Behavior; Stigma, Social; Stigmatization

Keywords

HIV; Tuberculosis; Stigma; Uganda

Outcome Measures

Primary Outcomes (1)

• Proportion of Contacts Accepting HIV Testing

  To test the hypothesis that a norming intervention can increase test uptake, the investigators will compare testing uptake among the intervention households and control households using cluster-adjusted chi-squared tests of proportion and by fitting mixed effects logistic regression models with two levels (household, contact). The effect of the intervention will then be evaluated by comparing adjusted slope differences in the primary outcomes (test uptake) between the intervention and the control arms, using random intercept mixed logit models to account for clustering by household.

  up to 8 weeks

Secondary Outcomes (6)

• Change in Score of Perceived HIV Stigma

  Baseline to End of Interview (Up to 8 hours)

• Change in Score of Perceived TB Stigma

  Baseline to End of Interview (Up to 8 hours)

• Change in Effects of Perceived HIV Stigma on HIV Test Uptake

  Baseline to Immediately post intervention (up to 8 hours)

• Change in Effects of Perceived TB Stigma on HIV Test Uptake

  Baseline to End of Interview (Up to 8 hours)

• Proportion of Index Patient Nominated Household Members Who Accept HIV Test

  up to 8 weeks

Other Outcomes (1)

• Count of Social Influence Nominations (Participants) by the Index Patient That Align With Nominations by the Household Contacts

  up to 8 weeks

Study Arms (2)

Social Support

EXPERIMENTAL

CHWs will offer HIV testing to the individual nominated by the index patient as most likely to test. If this person is not present, CHWs will decide which contact should be offered testing first. CHWs will use a prosocial script for HIV testing: "Knowing your status sets a good example for your household." CHWs will follow an "opt-out" strategy: "This test kit is approved by the Ministry of Health and used in KCCA health facilities. I am going to offer you a free HIV test now, is that okay?". If the initial household contact who is offered HIV testing agrees to test, the CHW will ask if he/she is willing to share his/her decision to test with other members of the household: "Would you like to share your decision to test with the others? Sharing is completely optional. However, learning that someone else in their household decided to test sometimes gives people the strength to test themselves. Sharing your decision might help another person find the strength to test."

Behavioral: Social Support

Standard of Care

NO INTERVENTION

As a control for the socio-behavioral intervention, the control arm will lack the socio-behavioral intervention components. The order of testing invitation will be decided by the CHW; and CHWs will be trained at baseline to provide standard, opt-in framing of test offers, without any mention of asking contacts to share their testing decision with other household contacts. Oral HIV kits will also be used in control households.

Interventions

Social Support BEHAVIORAL

The intervention to be evaluated in this study is a multidimensional, socio-behavioral "Norming" intervention. The various components of this intervention are designed to harness household dynamics and prosocial inclinations to encourage individuals to accept the HIV testing invitation. Each component is briefly described in the arm description.

Also known as: Intervention, Norming: Socio-Behavioral

Social Support

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Index Patient and Household Eligibility: * Index patient is eligible for contact investigation (TB patient of any age identified in the facility's National TB and Leprosy Programme (NTLP) TB Treatment Register as initiating treatment or returning for 2-week follow-up) * Index patient or legal guardian agrees to study procedures in addition to routine contact investigation * Index patient has at least 2 self-reported household contacts age 15 or above * Household is within the boundaries of the Kampala Capital City Authority, Uganda * Does not have multi-drug resistant (MDR) TB Contact Participant Eligibility: * Household contact age ≥15 years * Agrees to study procedures in addition to routine contact investigation

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Yale University: lead
• Fogarty International Center of the National Institute of Health: collaborator
• New York University: collaborator
• Makerere University: collaborator
• Walimu: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Makerere University

Kampala, Uganda

Location

Related Publications (2)

• Armstrong-Hough M, Ggita J, Gupta AJ, Shelby T, Nangendo J, Ayen DO, Davis JL, Katamba A. Assessing a norming intervention to promote acceptance of HIV testing and reduce stigma during household tuberculosis contact investigation: protocol for a cluster-randomised trial. BMJ Open. 2022 May 25;12(5):e061508. doi: 10.1136/bmjopen-2022-061508.

  PMID: 35613785 BACKGROUND

• Armstrong-Hough M, Gupta AJ, Ggita J, Nangendo J, Katamba A, Davis JL. Using group norms to promote acceptance of HIV testing during household tuberculosis contact investigation: A household-randomized trial. medRxiv [Preprint]. 2024 May 3:2024.05.02.24306703. doi: 10.1101/2024.05.02.24306703.

  PMID: 38746428 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Tuberculosis; Social Behavior; Social Stigma; Stereotyping

Interventions

Methods

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Dr. J. Lucian Davis
• Organization: Yale School of Public Health

lucian.davis@yale.edu

203-785-3665

Study Officials

• J. Lucian Davis, MD

  Yale School of Public Health

  PRINCIPAL INVESTIGATOR

• Achilles Katamba, PhD

  Makerere University

  PRINCIPAL INVESTIGATOR

• Mari Armstrong-Hough, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: There are 3 teams of community health workers (CHWs) in total: one intervention, one standard of care, and one clinic-based that will always carry out initial enrollment and record clinic follow-up for both arms. Blinding of the CHWs is not feasible because it is a behavioral intervention that is easily recognized and CHWs must be trained to deliver either the standard of care or the intervention strategy. CHWs will collect data for the outcomes. CHWs will be separated into two teams and will only have electronic permissions to access training, procedures, forms, and contact information related to their assigned allocation within the electronic case record forms. They will be blinded to randomization procedures and outcomes. Participants will be blinded to their randomization assignment. Investigators and study staff will be blinded to study outcomes until the database is locked at the end of the trial. The onsite study coordinator who manages randomization will not be blinded.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 18, 2021
• Study Start: October 25, 2021
• Primary Completion: July 29, 2022
• Study Completion: August 30, 2022
• Last Updated: February 14, 2024
• Results First Posted: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of main trial results. Data will be held by the researchers for a minimum of 7 years after the end of the trial.
• Access Criteria: A research proposal must be submitted to one of the principal investigators outlining the type of data needed as well as intended use of data.

Locations

UG (1)