Ignite Creation Date:
2024-05-06 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03016546
Status:
COMPLETED
Last Update Posted:
2020-08-17
First Post:
2017-01-06
Brief Title:
Integrating HIV and Depression Self-Care to Improve Adherence in Perinatal Women
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Integrating HIV and Depression Self-Care to Improve Adherence in Perinatal Women
Status:
COMPLETED
Status Verified Date:
2010-08
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:
None
Brief Summary:
Depression is a common perinatal complication that can have a profound adverse effect on maternal and child health outcomes The proposed study will directly address this important but understudied area by evaluating the feasibility and preliminary effect of an innovative integrated intervention approach BEST-maCARE Better Education Support Treatment for maternal Capacity Adherence REtention in care The multi-component intervention is guided by a model drawn from self-regulation and bioecological systems theory Proactive counseling personalized to the patient and socio-cultural context is delivered by trained clinic personnel eg counselors to build problem solving and coping skills and linkages to mental health HIV treatment and ancillary services The theory-guided intervention approach has been found effective in improving the health behavior and outcomes eg virologic of vulnerable marginalized HIV women and men in rural and urban settings in the US AI38858-ACTG 731 R01NR05108 Although the investigators formative research suggests that it is well suited for the target population its usefulness in addressing significant gaps in care among perinatal women
l women with co-morbid conditions in a different socio-cultural limited resource setting has not been studied
l women with co-morbid conditions in a different socio-cultural limited resource setting has not been studied
Detailed Description:
The investigators plan to examine the intervention among perinatal women in Bangalore India in a two phase developmental study The theory-guided core elements of the intervention will be maintained but the content and form of the intervention and study procedures that are contextsocio-culturally-specific will be adapted in the first phase of the study to enhance relevance and acceptability among the target population During the second phase of the project the investigators will train clinic personnel to deliver the intervention and then pilot test the feasibility acceptability and fidelity of the novel application of the intervention in a randomized controlled trial After baseline assessment participants n40 will be randomly assigned to BEST-maCARE or a time-matched attention control condition each delivered over 18 weeks and outcomes eg depressive symptoms adherence evaluated at 6 12 18 and 24 weeks post-randomization
The specific aims are
1 Conduct elicitation research with patients and providers in Maharashtra Delhi Bangalore and Varanasi India to gain a more nuanced understanding of the sociocultural context and womens perceived assets and barriers to care to guide adaptation of the Best-maCare intervention protocol to optimize socio-cultural relevance feasibility and acceptability among perinatal women with co-morbid HIV and depression in this setting
2 Evaluate the feasibility acceptability and fidelity of the study procedures and the adapted standardized Best-maCare and the attention control conditions and explore their preliminary effect in a randomized controlled pilot study
2a The investigators primary thesis is that the adapted Best-maCare will be feasible and acceptable to women living with HIV in Bangalore India and other stakeholders In addition we expect the fidelity of the intervention will be maintained and in keeping with the guiding conceptual framework that there will be a positive relationship between the Best-maCare intervention and womens medication adherence engagement in care HIV mental health 6-week postpartum health care services and health outcomes HIV-1 RNA depression 6-weeks postpartum visit
The focus of this registration is Aim 2
The specific aims are
1 Conduct elicitation research with patients and providers in Maharashtra Delhi Bangalore and Varanasi India to gain a more nuanced understanding of the sociocultural context and womens perceived assets and barriers to care to guide adaptation of the Best-maCare intervention protocol to optimize socio-cultural relevance feasibility and acceptability among perinatal women with co-morbid HIV and depression in this setting
2 Evaluate the feasibility acceptability and fidelity of the study procedures and the adapted standardized Best-maCare and the attention control conditions and explore their preliminary effect in a randomized controlled pilot study
2a The investigators primary thesis is that the adapted Best-maCare will be feasible and acceptable to women living with HIV in Bangalore India and other stakeholders In addition we expect the fidelity of the intervention will be maintained and in keeping with the guiding conceptual framework that there will be a positive relationship between the Best-maCare intervention and womens medication adherence engagement in care HIV mental health 6-week postpartum health care services and health outcomes HIV-1 RNA depression 6-weeks postpartum visit
The focus of this registration is Aim 2
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 |
|---|---|---|---|
| R21MH098667-01A1 | NIH | None | httpsreporternihgovquickSearchR21MH098667-01A1 |