Clinical trial NCT05124665: Interrupting HIV and TB Stigma in the Household in Uganda
Official title: Interrupting HIV and TB Stigma in the Household During TB Contact Investigation in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Tuberculosis
Social Behavior
Stigma, Social
Stigmatization
Keywords: HIV
Tuberculosis
Stigma
Uganda
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
name: New York University
name: Makerere University
name: Walimu
name: National Institute of Mental Health (NIMH)
First posted: 2021-11-18
Enrollment: 612
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: An estimated 39 million people worldwide are living with HIV, but nearly half do not know their status because they are unaware that they are at risk, unable to access counseling and testing, or unwilling to accept testing because of stigma and fear. Layered on to the stigma of HIV is the risk of tuberculosis (TB), the leading cause of death among persons living with HIV (PLWH). Home testing is a promising approach to increase testing and linkage to care for HIV because it can reach individuals outside the health system, eliminate the costs of traveling for testing, offer testing in a familiar environment, and increase engagement with care among those found to be living with HIV. Nevertheless, many individuals offered home HIV testing in sub-Saharan Africa decline to test.

The investigators developed a complex intervention to increase uptake of testing for HIV among household members by reducing perceptions of stigma associated with HIV and testing for HIV. The intervention involves lay health workers (LHWs) delivering a novel invitation strategy for HIV testing in households that includes 1) acceptance-optimized sequencing, 2) prosocial messaging, and 3) salivary HIV testing. The investigators will administer HIV and TB stigma scales before and after the invitation. The investigators will conduct a household randomized controlled trial to test the intervention's impact on household HIV stigma and uptake of testing among household members undergoing TB contact investigation. The investigators will measure our co-primary outcomes of HIV and TB stigma using standardized instruments before invitation and after completion of post-test counseling. The investigators will measure the proportion consenting to HIV testing, yield of HIV diagnoses, and the proportion of new PLWH linked to HIV care at 1 month and reassess household HIV and TB stigma at 3 months.

This study will be conducted in Kampala, Uganda, and will involve TB index patients and their household contacts. Households will be recruited and enrolled through index patients initiating treatment for pulmonary tuberculosis (PTB) at Kampala Capital City Authority health facilities. The investigators will enroll index patients and their households from Kiswa, Kawaala, and Kisenyi Health Centers, each a public-sector, primary care facility.

This study will enroll households (index patients + their household contacts). Only household contacts are eligible for participation; close contacts are not eligible. For the purposes of this study, household contacts are defined as those individuals "sleeping under the same roof" as the index patient for one or more nights within the past three months.

Upon encountering a patient initiating treatment for TB or returning for 2-week follow-up, study CHWs will assess index patients for household-level eligibility for the study. All index patients whose households meet these criteria will be asked to provide verbal consent after reviewing an information sheet. If the index patient is a minor (age \< 18 years), the guardian of the index patient will be asked to provide verbal consent.

After study enrollment, a CHW will work with the index patient and, if available, treatment supporter to schedule the home visit. Households will be randomly assigned to one of the two CHW teams to receive the intervention or standard or care strategy.

After the enrollment of the household through the index patient, household contact investigation will take place. All household contacts who meet these criteria will be asked to provide verbal consent after reviewing an information sheet. If the contact is a minor (aged 15-17), he or she will be asked to provide verbal assent with his/her parent/guardian providing consent. Enrolling in the study does not require eligibility for or consent to HIV testing. Those who choose to participate in the study and are eligible for HIV testing will be subsequently offered testing and may consent or decline. Those who choose to participate in the study and report conditions that render them ineligible for HIV testing, such as already known to be a PLWH, testing negative within the last three months, or currently in TB treatment, will not be offered HIV testing but will be eligible to participate in other study procedures.

Variable block randomization will be done at the level of the household and will be performed at the time of household enrollment. Block sizes will have a minimum of 4 households, a maximum of 8 households. The investigators will utilize Study Randomizer, an online randomization tool with concealed allocation, to generate the allocation sequence. When a CHW determines that an index patient is eligible for the study, and after the index patient or guardian has provided verbal informed consent, the CHW will place a phone call to the study coordinator. The study coordinator will then enroll the household using the Study Randomizer tool and let the CHW know the study allocation. The CHW will then record the appropriate allocation in the survey software, along with the randomization ID, and contact the appropriate CHW team for the household visit. The index patient will be given the name of the community health worker who will be visiting the household, and immediately connected with that person by telephone to arrange the home visit.

Households randomized to intervention group (Social Support Group) will be offered the social-behavioral intervention. Households randomized to the standard of care group (Standard of Care) will be offered oral testing without any social-behavioral intervention. CHWs will operate in teams that are always assigned to the same arm of the study. There will be three teams of CHWs in total: one intervention group, one standard of care group, and one clinic-based group that will always carry out initial enrollment of index patients and record any clinic follow-up by individuals in either arm of the study.

Regardless of intervention or control arm, CHWs will deliver a short, 13-item TB and HIV stigma scale to all household contacts at the beginning (prior to TB evaluation) and end of the household visit (after all TB and HIV procedures). The scale was adapted from the Van Rie TB HIV stigma scale specifically for this context. The scales will be administered first at the beginning of the home visit, then again at its conclusion.

The primary outcome is uptake of HIV testing, defined as the proportion of eligible individuals in the household who undergo testing after a test offer compared between the intervention arm and the standard of care arm..

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Contacts Accepting HIV Testing
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Change in Score of Perceived HIV Stigma
timeFrame: Baseline to End of Interview (Up to 8 hours)
measure: Change in Score of Perceived TB Stigma
timeFrame: Baseline to End of Interview (Up to 8 hours)
measure: Change in Effects of Perceived HIV Stigma on HIV Test Uptake
timeFrame: Baseline to Immediately post intervention (up to 8 hours)
measure: Change in Effects of Perceived TB Stigma on HIV Test Uptake
timeFrame: Baseline to End of Interview (Up to 8 hours)
measure: Proportion of Index Patient Nominated Household Members Who Accept HIV Test
timeFrame: up to 8 weeks
measure: Number of Social Support Household Contacts Deciding to Test for HIV
timeFrame: up to 8 weeks
Other outcomes:
measure: Count of Social Influence Nominations (Participants) by the Index Patient That Align With Nominations by the Household Contacts
timeFrame: up to 8 weeks
Locations:
city: Kampala
country: Uganda
facility: Makerere University
Study officials:
affiliation: Yale School of Public Health
name: J. Lucian Davis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Makerere University
name: Achilles Katamba, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York University
name: Mari Armstrong-Hough, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.