Clinical trial NCT01872390: Start TB Patients on ART and Retain on Treatment (START Study)
Official title: Start TB Patients on ART and Retain on Treatment: Combination Intervention Package to Enhance Antiretroviral Therapy Uptake and Retention During TB Treatment in Lesotho
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
HIV
Keywords: Lesotho
TB
tuberculosis
HIV
antiretroviral therapy
ART
adherence
combination intervention package
retention
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2013-06-07
Enrollment: 415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Measurement Cohort Participant 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 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

Primary outcomes:
measure: Percentage of TB/HIV patients newly registered during period of observation who initiate ART during TB treatment
timeFrame: Up to 9 months
measure: Percentage of participants who attended 6 month clinic visit (within 1 month window) and reported ART use
timeFrame: Up to 6 months after TB treatment initiation
measure: Participants with cure + treatment completion at end of TB treatment
timeFrame: Up to 9 months
Secondary outcomes:
measure: Days from TB treatment initiation to date of ART initiation
timeFrame: Up to 9 months
measure: Percentage of total prescribed doses ingested for ART
timeFrame: Up to 9 months
measure: Change in CD4+ count
timeFrame: Up to 6 months after initial CD4 count
measure: Percentage of smear positive pulmonary TB cases that converted to smear negative after eight weeks of treatment
timeFrame: Up to 8 weeks from initiation of TB treatment
measure: Percentage of total prescribed doses ingested for TB treatment
timeFrame: Up to 9 months
measure: Ratio of the incremental costs of the CIP to incremental effectiveness
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Koali
country: Lesotho
facility: Koali Health Center
city: Mafeteng
country: Lesotho
facility: Maluti Hospital
city: Mafeteng
country: Lesotho
facility: St. Magdalena Health Center
city: Maseru
country: Lesotho
facility: Khubetsoana Health Center
city: Maseru
country: Lesotho
facility: Pilot Health Center
city: Teyateyaneng
country: Lesotho
facility: Berea Hospital
city: Teyateyaneng
country: Lesotho
facility: Good Shepherd Health Center
city: Teyateyaneng
country: Lesotho
facility: Holy Family Health Center
city: Teyateyaneng
country: Lesotho
facility: Kolojane Health Center
city: Teyateyaneng
country: Lesotho
facility: Sebedia Health Center
city: Teyateyaneng
country: Lesotho
facility: St. David Health Center
city: Teyateyaneng
country: Lesotho
facility: St. Theresa Health Center
Study officials:
affiliation: Columbia University
name: Andrea A Howard, MD
role: PRINCIPAL_INVESTIGATOR
References: