Treatment to improve depression and adherence to antiretroviral therapy in people living with HIV in Zimbabwe (TENDAI) Among the Zimbabwe adult population, 350,000 are currently eligible for ART, a figure rising to 500,000 by 2015 (UNAIDS 2010). Depression causes considerable added disease burden among people living with HIV. However there have been no trials of depression treatment among people living with HIV in Africa. Longitudinal studies show an association between depression at baseline and HIV disease outcomes including HIV disease progression, poor adherence to antiretroviral therapy, and mortality. Lack of evidence on culturally appropriate and effective treatment models is a barrier in treating depression in PLWH in Africa.
The first aim of this proposal is to finalize an integrated intervention to treat depression and improve adherence to antiretroviral therapy in an antiretroviral therapy prescribing facility in Zimbabwe. To do this we will carry out qualitative testing to develop more understanding of our intervention, of the best method of delivering it, and of its possible effects.
The second aim i s conduct a pilot randomized controlled trial of this intervention compared to enhanced usual care, to test the feasibility for a future trial and to estimate the effect of the integrated depression-adherence intervention on antiretroviral adherence, CD4 lymphocyte count, and depression. The main aims of the exploratory trial are 1) to test the feasibility of recruiting and randomising PLWH with co-morbid depression into an RCT of the depression- adherence intervention 2) to monitor the delivery of the intervention using audio recording of 10% of sessions for each practitioner 3) to test ways of following up and minimizing drop out at 3 and 6 months 4) to determine a comparison arm for a future main trial and 5) to gather data to allow estimates to be made of the effect of the intervention to inform the sample required for a main trial. We will carry out the research through our dynamic collaborative partnership between researchers in Zimbabwe and outside faculty from the UK, US, and South Africa. Partnerships within the group are already strong, including collaboration over the PEPFAR/NIH-funded Medical Education Partnership Initiative (MEPI) award to the University of Zimbabwe College of Health Sciences. Capacity building will take place throughout the proposed study providing short courses in Zimbabwe taught by experts in the fields of research methods in mental health, in neurocognitive aspects of HIV and in integrated interventions at the intersection of psychology and health, and through 'learning by doing'with face-to-face and distance mentoring by partners from the Institute of Psychiatry and Bristol University UK, from Harvard Medical School and from the University of Cape Town. The partnership will work together to further define the research area and implement pilot studies.

Public Health Relevance

Depression causes considerable added disease burden among people living with HIV. However there have been no trials of depression treatment among people living with HIV in Africa. Among the Zimbabwe adult population, 350,000 are currently eligible for ART, a figure rising to 500,000 by 2015 (UNAIDS 2010). The proposed study will be the first of its kind. It will provide essential groundwork in demonstrating feasibilty for a future trial in Zimbabwe to test whether an intervention that integrates depression treatment with an intervention to improve adherence to antiretroviral therapy is better than standard care at improving adherence to antiretroviral therapy and at reducing depression.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21MH094156-01A1
Application #
8458844
Study Section
Special Emphasis Panel (ZRG1-AARR-F (55))
Program Officer
Stirratt, Michael J
Project Start
2013-04-11
Project End
2015-03-31
Budget Start
2013-04-11
Budget End
2014-03-31
Support Year
1
Fiscal Year
2013
Total Cost
$120,426
Indirect Cost
$8,920
Name
King's College London
Department
Type
DUNS #
231876178
City
London
State
Country
United Kingdom
Zip Code
WC2 -2LS