Start TB Patients on ART and Retain on Treatment (START Study)

Not Applicable

Completed

• Conditions: HIV; Tuberculosis
• Interventions: Other: Combination Intervention Package; Other: Standard of Care

• Registration Number: NCT01872390
• Lead Sponsor: Columbia University

Brief Summary

The purpose of the START Study is to identify an effective, cost-effective, acceptable intervention that addresses programmatic, structural and psychosocial barriers to ART initiation and retention during TB treatment, with the ultimate goal of improving health outcomes among HIV-infected TB patients in Lesotho. The study is a two-arm cluster randomized trial, randomized at the TB/HIV clinic level, which includes twelve TB/HIV clinics in Berea district. Clinics are randomized to deliver the combination intervention package (CIP) or standard of care (SOC), with stratification by facility type. The experimental intervention will be delivered to all HIV-infected TB patients in TB/HIV clinics randomly assigned to CIP. In TB/HIV clinics assigned to SOC, usual care procedures for ART initiation and retention will be delivered.

Study hypotheses focus on the effectiveness of the CIP on HIV- and TB-related outcomes.

Compared to HIV-infected TB patients attending SOC clinics, HIV-infected TB patients at CIP clinics will have superior HIV- and TB-related outcomes, including:

* Greater ART initiation during TB treatment

* Shorter time to ART initiation

* Greater retention in ART care

* Higher adherence to ART

* Greater change in CD4+ count

* Greater TB treatment success (completion and cure)

* Greater sputum smear conversion

* Higher adherence to TB treatment

Additionally, CIP delivery will have an incremental cost-effectiveness ratio more favorable than alternative resource uses.

Detailed Description

Among people living with HIV (PLWH), tuberculosis (TB) is the most common opportunistic illness and a leading cause of death, accounting for nearly a quarter of HIV-related deaths worldwide. Initiating antiretroviral therapy (ART) early during TB treatment significantly increases survival, and World Health Organization (WHO) guidelines recommend ART initiation for all PLWH as soon as possible after TB treatment initiation, regardless of CD4+ count. Yet in the African Region, only 42% of TB patients known to be living with HIV were on ART in 2010, and retention in ART programs has been limited. In Lesotho, only 27% of HIVinfected TB patients received ART in 2010. There is an urgent need to identify programmatic interventions that increase the proportion of HIV-infected TB patients on ART, shorten the duration between TB diagnosis and ART initiation, and improve adherence to medications and retention in care amongst HIV-infected TB patients in Lesotho.

Lesotho, a small, landlocked country completely surrounded by South Africa, is among the world's poorest nations with one of the world's most severe epidemics of HIV and tuberculosis (TB). There is strong evidence that TB patients who are also infected with HIV have better survival rates if they begin antiretroviral therapy (ART) soon after starting TB treatment; however, there are many patients who do not initiate ART within the recommended timeframe, and who do not remain in care.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-31
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-07
• Primary Completion: 2016-01
• Study Completion: 2021-05-07
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-12
• Last Update Posted: 2021-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 415

Inclusion Criteria

1. HIV-infected
2. On TB treatment
3. Initiating ART within 2 months of TB treatment initiation
4. Aged 18 or older
5. English- or Sesotho-speaking
6. Capable of informed consent

Measurement Cohort Participant

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Exclusion Criteria

1. Children under age of 18
2. Patients diagnosed with Multi Drug Resistant-TB (MDR-TB)

Key Informats: Three groups of key informats (KI) will be recruited.

• Key Informants ART Early-Initiators Inclusion Criteria:

  1. A measurement cohort participant
  2. Initiaing ART within the first 8 weeks of TB treatment

• Key Informants ART Non/Late-Initiators Inclusion Criteria:

  1. A measurement cohort participant
  2. did not initiate ART during TB treatment or initiating ART >= 2 months after TB treatment initiation

• Key Informants Healthcare Workers Inclusion Criteria:

  1. Nurse or VHW working in a CIP clinic or VHW working in the community and affiliated with CIP clinic
  2. Aged 18 or older
  3. English- or Sesotho-speaking
  4. Capable informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CIP Participants	Combination Intervention Package	Participants will receive the usual procedures (standard of care) for management of HIV-infected TB patients, and in addition the Combination Intervention Package (CIP) with the programmatic, structural, and psychosocial components.
SOC Participants	Standard of Care	Participants will receive the usual procedures (standard of care) for management of HIV-infected TB patients. TB and HIV services are fully integrated in a one-stop model, while at hospitals, ART is provided in the TB clinic for TB/HIV coinfected patients.

Primary Outcome Measures

Name	Time	Method
Percentage of TB/HIV patients newly registered during period of observation who initiate ART during TB treatment	Up to 9 months	To examine ART initiation based on review of clinic registers.
Participants with cure + treatment completion at end of TB treatment	Up to 9 months	To examine TB treatment success as defined by WHO, based on review of TB register and treatment cards.
Percentage of participants who attended 6 month clinic visit (within 1 month window) and reported ART use	Up to 6 months after TB treatment initiation	To examine ART retention. Deaths and transfers will be considered not retained.

Secondary Outcome Measures

Name	Time	Method
Days from TB treatment initiation to date of ART initiation	Up to 9 months	To examine Time to ART initiation
Ratio of the incremental costs of the CIP to incremental effectiveness	Up to 2 years	To examine incremental cost-effectiveness of CIP (per ART initiation, retention, and TB treatment completion)
Change in CD4+ count	Up to 6 months after initial CD4 count	To examine change in CD4 count over 6 months (from initiation of TB treatment to 6 months later). Routine clinical CD4 test results will be used by study staff and no additional blood draw will be required.
Percentage of total prescribed doses ingested for ART	Up to 9 months	To examine ART adherence, averaged across medicines for each month of treatment, from the unannounced pill counts.
Percentage of smear positive pulmonary TB cases that converted to smear negative after eight weeks of treatment	Up to 8 weeks from initiation of TB treatment	To examine sputum smear conversion
Percentage of total prescribed doses ingested for TB treatment	Up to 9 months	To examine TB treatment adherence, from unannounced pill counts.

Trial Locations

Locations (12)

Berea Hospital; 🇱🇸 Teyateyaneng, Lesotho

St. Theresa Health Center; 🇱🇸 Teyateyaneng, Lesotho

Koali Health Center; 🇱🇸 Koali, Lesotho

Maluti Hospital; 🇱🇸 Mafeteng, Lesotho

Holy Family Health Center; 🇱🇸 Teyateyaneng, Lesotho

St. Magdalena Health Center; 🇱🇸 Mafeteng, Lesotho

Good Shepherd Health Center; 🇱🇸 Teyateyaneng, Lesotho

Khubetsoana Health Center; 🇱🇸 Maseru, Lesotho

Pilot Health Center; 🇱🇸 Maseru, Lesotho

St. David Health Center; 🇱🇸 Teyateyaneng, Lesotho

Kolojane Health Center; 🇱🇸 Teyateyaneng, Lesotho

Sebedia Health Center; 🇱🇸 Teyateyaneng, Lesotho