Kulindana: Community-based TB Preventive Therapy Delivery to Boost Uptake

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will compare a community-based, differentiated-service delivery approach for TB preventive therapy to standard clinic-based care in seven HIV clinics in Kisumu County, Kenya. The study uses a two-arm, non-blinded randomized design to see if decentralized TPT initiation and multi-month dispensing increases uptake and completion within 16 weeks. Participants include household contacts of index TB patients and people living with HIV who are eligible for TPT. The primary outcome is completion of a full 11-week TPT course by 16 weeks after enrollment. The trial aims to assess whether reduced clinic visits and home-based initiation can also lower TB transmission in the community.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Household contacts (HHC) are eligible for enrolment if the participant shares a residential dwelling with an index TB patient and can provide informed consent (or parental consent, with assent if appropriate).
* People living with HIV (PWH) are eligible for enrolment if the participant is an adult aged 15 and over, is eligible for TPT according to Kenyan National Guidelines, and can provide informed consent.

Exclusion Criteria:

* HHC will be excluded if the participant plans on permanently relocating from the area within the next three months, is not willing to receive TPT screening and initiation at home, or is enrolled in any other investigational/interventional HIV or TB study.
* PWH will be excluded if the participant plans on permanently relocating from the area within the next three months, has contraindications for TPT according to the Kenyan National Guidelines, or is enrolled in any other investigational/interventional HIV or TB study.

Where it's running

• Centre for Family Health Research and Development (CEFERD) located at Jaramogi Oginga Odinga Teaching and Referral Hospital
  Kisumu, Kenya Recruiting

Study contacts

• Principal investigator: Adrienne Shapiro, MD, PhD — University of Washington
• Study coordinator: Gillian O'Bryan
• Email: gilliano@uw.edu
• Phone: 240-444-0098

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Project SHIELD 2.0: Police Education to Support Public Health in Kentucky

  Aimed at police in Kentucky, this program tests whether SHIELD training given to officers, with health workers helping deliver it, can reduce drug-related arrests and steer people who use drugs toward MOUD and other health services.

  Recruiting Johns Hopkins Bloomberg School of Public Health · Lexington, Kentucky · NCT07804121

• New ways to diagnose lymphoma and multicentric Castleman disease in people living with HIV

  This study tests a quick, point-of-care nucleic acid test to help diagnose lymphoma and multicentric Castleman disease in people living with HIV in sub-Saharan Africa.

  Recruiting Indiana University · Lilongwe · NCT07793006

• Bridge to Belonging: A Peer‑Led Program to Reduce Loneliness and Depression in older gay and bisexual men with HIV

  This program tests a peer-delivered, manualized approach to help men aged 50+ with HIV connect to LGBTQ+-affirming elder services to see if it reduces loneliness and depressive symptoms.

  Recruiting Fenway Community Health · Boston, Massachusetts · NCT07762066

• rBCG-N-RSV vaccine test in adults 60+ compared with standard BCG

  This phase 2 study tests whether the rBCG-N-RSV vaccine is safe in adults over 60 and how its immune effects compare to conventional BCG.

  Recruiting Phase 2 Biothervax SpA · Athens · NCT07762014

• HIV vaccine test in healthy adults using CH505 nanoparticles and mRNA boosters

  This early-stage study will test the safety and immune responses of CH505 vaccine regimens in healthy adults to see if they can trigger HIV-specific immune protection.

  Recruiting at 2 sites Phase 1 National Institute of Allergy and Infectious Diseases (NIAID) · San Francisco, California and 7 other locations · NCT07757802

• Stigma-reducing program to help women who use drugs stay in HIV care

  This test checks whether a stigma-reduction program helps women living with HIV who use drugs stay engaged in HIV care in Ukraine.

  Recruiting Johns Hopkins Bloomberg School of Public Health · Kyiv, Kyiv Oblast · NCT07751978

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.