Interrupting HIV and TB Stigma in the Household in Uganda

Hiv Clinical Trial

Official title: Interrupting HIV and TB Stigma in the Household During TB Contact Investigation in Uganda

Status Completed

Clinical Trial 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.

Clinical Trial 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.. ;

Related Conditions & MeSH terms

• Hiv
• Social Behavior
• Stigma, Social
• Stigmatization
• Tuberculosis

• NCT number: NCT05124665
• Study type: Interventional
• Source: Yale University
• Status: Completed
• Phase: N/A
• Start date: October 25, 2021
• Completion date: August 30, 2022