Health TrialsbyHealthPanel

Integrating Tuberculosis Treatment Into Community Pharmacies to Improve TB/HIV Outcomes in Uganda

ConditionsTB - TuberculosisHIV - Human Immunodeficiency Virus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMakerere University

About this trial

Community pharmacies (CPs) have emerged as promising differentiated service delivery models for refilling antiretroviral therapy (ART) among people with human immunodeficiency virus (HIV). Documented benefits of CP-based refills include improved treatment adherence and viral suppression, reduced healthcare provider workload, and reduced facility congestion. This trial will evaluate the acceptability, feasibility, fidelity, and preliminary effectiveness of integrating TB treatment into CPs among people with TB/HIV in Kampala, Uganda.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

People with TB/HIV aged ≥18 years, receiving treatment for bacteriologically confirmed or clinically diagnosed drug-susceptible pulmonary TB, on a first-line ART regimen or its alternative, and receiving TB treatment for ≤2 months.

Disqualifiers

Individuals with extrapulmonary TB as their treatment often exceeds 6 months, and those likely to transfer to other health facilities.

Trial design

Design model

Parallel

Treatments tested in this trial

  • The intervention is TB treatment delivery via community pharmacies for people with TB/HIV

    Other intervention

    Before randomization (months 0-2), all participants will receive standard TB treatment (2RHZE/4RH) and ART according to national guidelines. They will attend the health facility for TB care, treatment-stability assessments, standardized counseling and health education. TB and ART medications will be refilled biweekly, and participants with bacteriologically confirmed pulmonary TB will undergo sputum smear examination at month 2, per national guidelines. Eligible participants will then be randomized 1:1 to community pharmacy-based refills or treatment as usual. Accordingly, participants in the community pharmacy-based refill (intervention) arm will receive TB and ART refills through participating community pharmacies in 2-month supplies (months 3-4 and 5-6). At month 6, bacteriologically confirmed participants will undergo sputum smear examination at the health facility. Those discontinuing community pharmacy-based refills will return to routine care.

  • Control Arm - standard of care

    Other intervention

    Before randomization (months 0-2), all participants will receive standard TB treatment (2RHZE/4RH) and ART according to national guidelines. They will attend the health facility for TB care, treatment-stability assessments, standardized counseling and health education. TB and ART medications will be refilled biweekly, and participants with bacteriologically confirmed pulmonary TB will undergo sputum smear examination at month 2, per national guidelines. Eligible participants will then be randomized 1:1 to community pharmacy-based refills or treatment as usual. Participants randomized to the treatment as usual (control) arm will receive TB refills monthly and ART refills every 2-3 months at the facility.

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: Community pharmacy refill armExperimental treatment 1 intervention
Group B: Health facility refill armPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Acceptability of integration of TB treatment into community pharmacies

Proportion of people with TB/HIV willing to receive treatment at community pharmacies.

Time frame
6 months

Secondary outcomes

1

Feasibility of integration of TB treatment into community pharmacies

Proportion of community pharmacy workers reporting that the integration of TB treatment into community pharmacies was successful.

Time frame
6 months
2

Fidelity of implementation of community pharmacy TB treatment integration

Proportion of people with TB/HIV who return for expected refills.

Time frame
6 months
3

TB treatment success rate

Proportion of people with TB/HIV with treatment outcomes of cure or treatment completion at 6 months

Time frame
6 months
4

Viral load suppression

Proportion of people with TB/HIV with viral load \<1,000 copies/ml at 6 months or TB treatment completion

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Makerere University

Lead sponsor

Fogarty International Center of the National Institute of Health

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: