Adaptive evaluation of mhealth and conventional adherence support interventions to optimize outcomes with new treatment regimens for drug-resistant tuberculosis and HIV in south africa

Active Project Grant Awarded Last action

Award ID
R01AI167795
Recipient
Awarding agency
Obligated
$6,316,676

Award facts

Assistance listing
93.855 Allergy and Infectious Diseases Research
Completion date 93% complete
Place of performance
New York, NY 10032, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Tuberculosis (TB) is the leading cause of mortality among people living with HIV, causing one in three deaths world-wide. In southern africa, interaction between TB and HIV epidemics has led to increased transmission of drug-resistant TB (DR-TB), critically undermining both TB and HIV- related treatment targets. Bedaquiline (BDQ) is the first new TB drug in over 40 years, and the world health organization recommends the inclusion of BDQ in DR-TB treatment allowing for more effective, entirely oral DR-TB treatment. Despite challenges, BDQ rollout in south africa has been highly successful in reducing TB associated-mortality and improving cure rates. Dolutegravir, an integrase strand transfer inhibitor, formulated as part of a once-daily combination antiretroviral therapy (art), is newly available in the south african public health system. Tenofovir/lamivudine/dolutegravir (TLD) is superior to older comparator regimens, protective for discontinuation due to adverse events, and has minimal interaction with BDQ. The availability of TLD and BDQ has radically transformed the treatment paradigm for DR-TB HIV but advances in dual adherence support are needed to realize the benefits of new therapeutics for patients, and to prevent emergent resistance. Patient-centered adherence support strategies using psychosocial support and mhealth (health practices supported by mobile technologies) approaches may improve DR-TB HIV outcomes. The goal of the proposed study is to evaluate an integrated intervention to enhance adherence to BDQ and TLD. Using a bayesian, adaptive randomized trial design, this project will efficiently evaluate the relative contribution of psychosocial support and cellular-supported mhealth adherence support, in combination and separately, to improve clinical and biological outcomes for HIV and TB. BDQ adherence measured using cellular-enabled electronic pill boxes, will allow US to determine optimal adherence thresholds associated with TB culture conversion. We will use a model-based approach to characterize socio-behavioral mechanisms of action for the different intervention arms (including potential non-response), and modifiable factors that present barriers and facilitators to adherence. We will also evaluate the effect of DR-TB HIV intersectional stigma on adherence. Qualitative methods will allow for longitudinal description of patient- centered treatment pathways. Once completed, this study will meet the expressed need of the south african health system for evidence-based DR-TB HIV adherence interventions and contribute generalizable knowledge about the relative contributions of adherence support modalities in medically complex patients.

Transactions

Action Obligated Date
Amendment $14,040
Amendment $223,142
Amendment $316,381
Amendment $14,040
Amendment $14,040
Amendment $280,026
Amendment $280,026
Amendment $256,000
Amendment $256,000
Amendment $56,645
Amendment $509,806
Amendment $509,806
Amendment $583,702
Amendment $583,702
Amendment $583,702
Amendment $583,702
Amendment $625,958
Original award $625,958
Show all 18

Subawards

Subrecipient Amount Awarded
Touro University Dr. Jennifer Zelnick, based at the Touro College Graduate School of Social Work, has extensive experience working with social workers in the South African… $26,589
Regents Of The University Of Michigan K. Rivet Amico, PhD, will work closely with the core team in intervention development, identification of measures, qualitative guides and mixed methods… $36,855
York University Dr. Amrita Daftary is a qualitative researcher and has contributed to development of the study aims and design. She has the expertise to lead qualitative data… $14,040
Centre For The Aids Program Of Research In South Africa "In general, the work at CAPRISA will be led by Dr. Naidoo working with Dr. O’Donnell and all collaborators to design protocols, obtain local ethics approval,… $223,142
Regents Of The University Of Michigan "K. Rivet Amico, PhD, will work closely with the core team in intervention development, identification of measures, qualitative guides and mixed methods… $25,816
Touro University Dr. Jennifer Zelnick, based at the Touro College Graduate School of Social Work, has extensive experience working with social workers in the South African… $25,816
York University Dr. Amrita Daftary is a qualitative researcher and has contributed to development of the study aims and design. She has the expertise to lead qualitative data… $11,934
Regents Of The University Of Michigan K. Rivet Amico, PhD, will work closely with the core team in intervention development, identification of measures, qualitative guides and mixed methods… $32,908
Touro University Dr. Jennifer Zelnick, based at the Touro College Graduate School of Social Work, has extensive experience working with social workers in the South African… $25,065
Centre For The Aids Program Of Research In South Africa These studies will be conducted within the established research infrastructure of the Centre for the AIDS Programme of Research in South Africa (CAPRISA) TB… $312,315
Centre For The Aids Program Of Research In South Africa STATEMENT OF WORK These studies will be conducted within the established research infrastructure of the Centre for the AIDS Programme of Research in South… $312,315
Show all 11

Quick answers

Who received award R01AI167795?

R01AI167795 was awarded to The Trustees Of Columbia University In The City Of New York by National Institute of Allergy and Infectious Diseases (National Institutes of Health) on March 10, 2022.

How much is award R01AI167795 worth?

$6,316,676 has been obligated on R01AI167795.

On GovTribe

See this award's full record

  • Every transaction and subaward
  • The recipient's other awards and teaming partners
  • Similar grant awards
  • Ask GovTribe AI about this award
Try for free Login