Community-based tuberculosis prevention in South Africa
ThiPhiSA: New Pathways to Prevention From Community TB Screening in South Africa
NA · University of Washington · NCT06214910
This study tests if giving tuberculosis prevention treatment in the community helps South African adults, especially those with HIV, finish their treatment better than getting it at a clinic.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 525 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington (other) |
| Locations | 1 site (Sweetwaters, KwaZulu-Natal) |
| Trial ID | NCT06214910 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of community-delivered multi-month tuberculosis preventive therapy (TPT) to standard clinic-based delivery among South African adults recommended for TPT. The research aims to identify barriers to TPT completion and assess whether community delivery leads to higher completion rates. Participants will be randomized to receive either immediate multi-month TPT or a shorter supply with a referral for clinic completion. The study also includes qualitative interviews to explore factors influencing TPT initiation and adherence, particularly among individuals living with HIV.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are living with HIV or are household contacts of individuals with active TB.
Not a fit: Patients who are under 18 years old, pregnant, or planning to relocate within three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the completion rates of tuberculosis preventive therapy, thereby reducing the incidence of TB in the community.
How similar studies have performed: Other studies have shown promise in community-based health interventions, suggesting that this approach could be effective, although this specific methodology may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Meet eligibility criteria for TB preventive therapy by South African national guidelines: is a person living with HIV -or- is a household contact of someone with active TB. * Screened negative for active TB disease through TB screening activities within 6 months. * Negative symptom screen at the time of enrollment if TB screening was more than 3 months prior to enrollment. * Reside in the study community. * Willing and able to complete informed consent Exclusion Criteria: * Less than 18 years of age. * Pregnant or planning on pregnancy within next three months * Planning on moving or relocating from the area within the next three months
Where this trial is running
Sweetwaters, KwaZulu-Natal
- Human Sciences Research Council — Sweetwaters, KwaZulu-Natal, South Africa (RECRUITING)
Study contacts
- Principal investigator: Adrienne E Shapiro, MD, PhD — University of Washington
- Study coordinator: Meena R Lenn
- Email: mlenn@uw.edu
- Phone: 206-543-7140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tuberculosis, HIV I Infection, TPT, 3HP, differentiated service delivery, multi-month dispensing