Ignite Creation Date:
2024-05-06 @ 8:33 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02764853
Status:
COMPLETED
Last Update Posted:
2019-12-18
First Post:
2016-05-03
Brief Title:
Striving Towards EmPowerment and Medication Adherence STEP-AD
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Striving Towards EmPowerment and Medication Adherence STEP-AD
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEP-AD
Brief Summary:
Striving Towards Empowerment and Medication Adherence STEP-AD is a research study aimed at developing an intervention for Black women living with HIV to address psychosocial factors ie abusetrauma histories racial discrimination HIV stigmadiscrimination and prescribed traditional gender roles that have been associated with medication nonadherence or poor HIV outcomes eg viral load CD4 but are unaddressed in existing interventions
Detailed Description:
Among Black women with HIV in the US generally low rates of adherence to ART are likely due to relevant psychosocial and contextual factors facing Black women with HIV such as having a history of physical sexual and emotional abuse post traumatic stress racial discrimination and contextual variables related to traditional gender roles each of which are associated with worse HIV outcomes
Despite the need there is currently no evidenced-based psychosocial intervention for Black women with HIV that addresses these contextual factors to improve adherence to HIV self-care A psychosocial intervention including content on reducing the effects of trauma and discrimination and increasing resilient coping strategies and gender empowerment may be most culturally appropriate and therefore effective in improving quality of life and increasing treatment adherence in Black women living with HIVAIDS
Striving Towards Empowerment and Medication Adherence STEP-AD is a research study aimed at developing an intervention for Black women living with HIV to address psychosocial factors ie abusetrauma histories racial discrimination HIV stigmadiscrimination and prescribed traditional gender roles that have been associated with medication nonadherence or poor HIV outcomes eg viral load CD4 but are unaddressed in existing interventions
Individual in-depth qualitative interviews n30 were conducted with Black women with HIV and community stakeholders to gather information on the perceived acceptability and to inform the development of a manualized intervention of an integrated treatment to improve ART adherence by addressing trauma symptoms racial discrimination HIV discrimination and gender related stressors experienced by Black women with HIV This information was used to develop the resulting intervention
An open pilot trial n5 of the resulting intervention was conducted December 2015 through August 2016 in order to initially assess the feasibility of all study procedures and intervention delivery acceptability and a potential clinically significant improvement on ART adherence and hypothesized psychosocial mediators
A pilot randomized control trial RCT comparing the newly developed intervention N25 to an enhanced treatment as usual control N25 on ART adherence primary outcome and viral load secondary outcome over 6 months baseline 10 weekly treatment visits approximately 3 months and a 6 month follow-up begun enrolling participants as of August 2016
Actual enrollment at baseline for all the phases are below Please note that not all participants enrolled at baseline moved on to the relevant phase due the need to meet inclusion criteria
Formative qualitative phase 30 Black women living with HIV 15 community Stakeholders
Open Pilot phase 20 Black women living with HIV
Pilot RCT 119 Black women living with HIV
Total 184
Despite the need there is currently no evidenced-based psychosocial intervention for Black women with HIV that addresses these contextual factors to improve adherence to HIV self-care A psychosocial intervention including content on reducing the effects of trauma and discrimination and increasing resilient coping strategies and gender empowerment may be most culturally appropriate and therefore effective in improving quality of life and increasing treatment adherence in Black women living with HIVAIDS
Striving Towards Empowerment and Medication Adherence STEP-AD is a research study aimed at developing an intervention for Black women living with HIV to address psychosocial factors ie abusetrauma histories racial discrimination HIV stigmadiscrimination and prescribed traditional gender roles that have been associated with medication nonadherence or poor HIV outcomes eg viral load CD4 but are unaddressed in existing interventions
Individual in-depth qualitative interviews n30 were conducted with Black women with HIV and community stakeholders to gather information on the perceived acceptability and to inform the development of a manualized intervention of an integrated treatment to improve ART adherence by addressing trauma symptoms racial discrimination HIV discrimination and gender related stressors experienced by Black women with HIV This information was used to develop the resulting intervention
An open pilot trial n5 of the resulting intervention was conducted December 2015 through August 2016 in order to initially assess the feasibility of all study procedures and intervention delivery acceptability and a potential clinically significant improvement on ART adherence and hypothesized psychosocial mediators
A pilot randomized control trial RCT comparing the newly developed intervention N25 to an enhanced treatment as usual control N25 on ART adherence primary outcome and viral load secondary outcome over 6 months baseline 10 weekly treatment visits approximately 3 months and a 6 month follow-up begun enrolling participants as of August 2016
Actual enrollment at baseline for all the phases are below Please note that not all participants enrolled at baseline moved on to the relevant phase due the need to meet inclusion criteria
Formative qualitative phase 30 Black women living with HIV 15 community Stakeholders
Open Pilot phase 20 Black women living with HIV
Pilot RCT 119 Black women living with HIV
Total 184
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K23MH108439 | NIH | None | None |
| 2016P001464 | OTHER | None | None |
| 20170281 | OTHER | UMiami | httpsreporternihgovquickSearch1K23MH108439 |