An Adaptive Randomized Controlled Trial

HIV Infections Clinical Trial

— ADAP-TIV  

Official title:

Adaptive Evaluation of mHealth and Conventional Adherence Support Interventions to Optimize Outcome With New Treatment Regimens for Drug-resistant Tuberculosis and HIV in South Africa

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05633056
• Other study ID #: CAP262
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2023
• Est. completion date: February 2027

Study information

• Verified date: November 2022
• Source: Columbia University
• Contact: Kogieleum Naidoo, Prof
• Phone: +27 31 260 4687
• Email: Kogie.Naidoo[@]caprisa.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, adaptive, randomized controlled trial comparing the effectiveness of 4 intervention arms on a combined endpoint in adults with confirmed MDR-TB HIV initiating Bedaquiline-containing MDR-TB treatment regimens and on ART (integrase strand transfer inhibitor (INSTI)-based fixed dose combination therapy) in KwaZulu-Natal, South Africa. Interventions arms include: enhanced standard of care; psychosocial support; mHealth using cellular-enabled electronic dose monitoring; combined mHealth psychosocial support. Level of support will be adjusted using a differentiated service delivery (DSD)- informed assessment of treatment support needs.

Description:

This study will follow a 4-arm Bayesian, adaptive trial design. As patients are enrolled, they will be randomized into one of the four arms. The study will be carried out within a common structure to allow for efficient enrollment and analysis. The overall structure is a 4-arm adaptive platform of mHealth and psychosocial adherence support interventions informed by a differentiated service delivery (DSD) approach. Aim 1 is an adaptive study of mHealth and psychosocial adherence support interventions using a Bayesian adaptive design to allow comparison of elements of the intervention separately and in combination. Aim 1 participants will be randomized into one of 4 arms and followed monthly through the 6 months of intervention, then through the end of treatment telephonically, with an additional in-person visit to establish the primary outcome. Primary outcome is a combined clinical/biological outcome at 12 months described below. Hypothesis 1a utilizes all participants while 1b utilizes only those in the mHealth intervention arms (3+4) since granular EDM-measured adherence is required.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: February 2027
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Culture or molecular test positive for MTB

2. Molecular test positive for HIV or a documented HIV positive history

3. Drug-susceptibility testing by molecular (i.e. GeneXpert MTB/RIF) or conventional testing consistent with at least rifampicin-resistant TB,

4. Initiating treatment with a Bedaquiline -containing TB regimen within 4 weeks of enrollment and first-time being treated with BDQ

5. On treatment with Antiretroviral Therapy (ART) regimen, including dolutegravir-containing combination Antiretroviral Therapy regimen (i.e. Tenofovir-Lamivudine-Dolutergravir), or starting within 4 weeks of enrollment,

6. Capacity for informed consent in either isiZulu or English

Exclusion Criteria:

1. Pregnancy

2. Prisoners

3. Discretion of IOR or clinician

Related Conditions & MeSH terms

• HIV Infections
• Multi Drug Resistant Tuberculosis
• Tuberculosis
• Tuberculosis, Multidrug-Resistant

Intervention

Behavioral:
• Adherence support intevention
Compare the effects of adherence support interventions on clinical and biological endpoints using an adaptive randomized platform.

Locations

Country	Name	City	State
South Africa	King DinuZulu Hospital	Durban	KwaZulu-Natal

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Centre for the AIDS Programme of Research in South Africa

Country where clinical trial is conducted

South Africa, 

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* Note: There are 83 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biological outcome	TB culture conversion	06 months
Primary	Clinical outcome	Survival	12 months
Primary	Biological outcome	HIV viral load	12 months
Primary	Clinical outcome	Retention in care	12 months
Primary	Biological outcome	TB culture conversion	12 months

External Links

•   WHO World Health Organization. The end of TB strategy.2015