The Uganda's Ministry of Health (MOH) in October 2012 adopted Option B+ (life-long triple antiretroviral therapy [ART]) for the prevention of mother-to-child HIV transmission (PMTCT). The national scale up of option B+ provides an opportunity to eliminate mother-to-child HIV transmission (MTCT) in Uganda. However, adherence to life-long triple ART by HIV-infected pregnant women in resource-limited settings presents unique challenges given disruptions in normal routines often with travel upcountry and difficulties of life time adherence among generally healthy women after the risk of transmitting HIV to their infant has ceased. The overall goal of this operational research to be conducted in urban and rural Uganda is to improve adherence to option B Plus among HIV-infected pregnant and newly delivered mothers. We will use formative research followed by a randomized clinical trial of an enhanced compare a community based intervention to improve maternal adherence to appointments and taking ARVs. Our hypothesis is that the community-based peer group support strategy called 'Friends for Life Circles'combining drug access, health education and income- generating activities will be more effective to support women to adhere to their treatment and care visits and to their drugs to achieve and maintain viral suppression and minimize MTCT of HIV when compared to the current MOH approach to support mothers adherence to option B+.
The specific aims of this operational research are:
AIM 1 : To conduct formative research to assess individual, family and community attitudes regarding Option B plus.
AIM 2 : To conduct a randomized controlled trial that compares community-based peer group support versus Ministry of Health hospital-based standard of care for Option B plus.
AIM 3 : To evaluate the adherence to option B plus and effectiveness of the community- based peer group support intervention compared to Ministry of Health hospital-based standard of care for Option B plus. The formative research will inform the implementation of the community-based group peer support intervention. The research will be conducted as a randomized clinical trial. A total of 540 evaluable HIV-infected women enrolled during pregnancy will be randomized to either Friends for Life Circles (FLC) or the standard MOH counseling on adherence in a rural and an urban district of Central Uganda. HIV-infected women assigned to the group peer support (FLC) arm will meet on a monthly basis in the community and participate in the circles. Group sessions will include drug distribution, counseling on adherence to ARVs and follow-up visits, male partner disclosure, infant feeding and nutrition, and promotion of psychosocial well-being. Income-generating activities will be used to foster sustainability of the Circles after the period of risk of transmission of HIV to the infant has ceased. In partnership with the MOH, the findings from the Friends for Life Circles will be evaluated and the successful components and lessons learned will be documented to inform the scaling up of the intervention within the districts and nationally.

Public Health Relevance

This project will use enhanced peer group strategies to support the recently recommended Option B + (lifelong triple antiretroviral treatment [ART]) for the prevention of mother-to-child HIV transmission (PMTCT) in Uganda. The Friends for Life Circles, a community-based peer group support intervention designed to support adherence of HIV infected women on Option B + will include community-based drug distribution, income generating activities to help support, bond and sustain the group as well as counseling on ARV adherence, male partner disclosure, nutrition education, and family planning counseling over a 24-36 month period - depending on the timing of enrollment. This community-based strategy will be compared to the standard of care through an open-label randomized controlled trial in both a rural and an urban Ugandan health district in order to increase generalizability of results.

Agency
National Institute of Health (NIH)
Type
Research Project (R01)
Project #
1R01HD080476-01
Application #
8729113
Study Section
Special Emphasis Panel (ZHD1)
Program Officer
Siberry, George K
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Mu-Jhu Care
Department
Type
DUNS #
City
Kampala
State
Country
Uganda
Zip Code
23491