Wednesday, May 28, 2025
5/28/2025
DEVELOPMENT OF AN HIV MEDICATION ADHERENCE INTERVENTION VIA VIDEOPHONES - DESCRIPTION (provided by applicant): The purpose of the proposed study is to develop and pilot-test effects of a cognitive intervention, Space Retrieval (SPARE), embedded within an adherence counseling program, HAART CARE (HC), and delivered via videophone, on antiretroviral therapy (ART) adherence. Adherence outcomes will be monitored by an innovative method-unannounced pill counts (UPCs) conducted via videophone. HC + SPARE will be compared with a HC only condition in persons living with HIV in either a rural or urban area, and with or without cognitive impairment. In the formative stage, 40 persons, age 18 years or older, who self-report less than 75% ART adherence will be recruited, with half (n=20) living in an urban area (Greater Cleveland, OH), and half (n=20) in a rural area (near Athens, OH); half at each site will meet criteria for cognitive impairment and half will not. These participants will be provided eight HC only treatment sessions individually via videophone. ART adherence (UPC-via videophone and self-report) and health outcomes (HIV quality of life, viral load and CD4 count) will be assessed at baseline, and at 1-week, 1-month and 3-months post-intervention. For 20% of all UPC-videophone assessments, a concurrent in-person UPC will be conducted at the participant's home. Objectives of this stage are to determine: 1) How well videophones are accepted by persons with HIV in urban and rural settings; 2) Barriers to utilization of videophones; 3) How to collect adherence measures (UPCs and self-reports) via videophones; 4) How to deliver HC via videophone; 5) How to initially assess effects produced by an adherence intervention delivered via videophone; and 6) How UPCs conducted via videophone compare with UPCs conducted in-person. Next, in a manualization stage, videophone delivery of both HC only and HC + SPARE will be refined. Objectives of this stage are to develop manualized procedures for videophone: 7) Conducting UPCs; 8) Delivering HC only; and 9) Delivering HC + SPARE. Finally, in a randomized control trial (RCT) stage, 80 persons, age 18 years or older, who self-report less than 75% ART adherence will be recruited. Again, half (n=40) will come from the urban site, and half (n=40) from the rural site; half at each site will meet criteria for cognitive impairment and half will not. At each site, half of the participants will be randomly assigned to receive HC only and half HC + SPARE. Adherence and health outcomes will be measured at baseline, 1-week, 1-month and 3-months post-intervention. Objectives of this stage are to determine: 10) How well manualized procedures for delivering HC only and HC + SPARE can be implemented via videophone; 11) The effectiveness of the HC + SPARE intervention compared to HC only as an adherence intervention delivered via videophone; 12) The relationship between level of cognitive impairment and the interventions' effects; and 13) The influence of Rural vs. Urban environments. This study will address a critical yet neglected factor in ART adherence, cognitive impairment; further develop an intervention to compensate for it; and use innovative technology, videophones, to both deliver the intervention and measure its effect on adherence.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).