Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06182241
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-01
First Post:
2023-11-30
Brief Title:
Identifying and Addressing Barriers to Retention in the Cervical Cancer Treatment Cascade Among Women With HIV in South Africa Part 2
Sponsor:
Boston University Charles River Campus
Organization:
Boston University Charles River Campus
Study Overview
Official Title:
Identifying and Addressing Barriers to Retention in the Cervical Cancer Treatment Cascade Among Women With HIV in South Africa Part 2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
The investigators will conduct the formative work that is necessary to develop a novel multi-level intervention inclusive of patient- and provider-level components which will increase awareness of and modify the complex intersecting factors that contribute to cervical cancer development among cisgender women with HIV WWH In Aim 1a the investigators will explore the multi-level barriers and facilitators to follow-up appointment attendance among WWH who have had a recent high-risk abnormal Pap smear in the past six months via qualitative interviews with WWH who have either attended at least one follow-up visit n10 or have not yet attended a follow-up visit n10 In Aim 1b the investigators will explore provider awareness of the HIV-cervical cancer relationship and perspectives on barriers to retention in care via qualitative interviews n8 For Aim 2 The study team will leverage the Aim 1 data develop a patient-level intervention 1-2 sessions and a provider toolkit with the goal of increasing retention in care among WWH who are at heightened risk for cervical cancer The study team will seek feedback on the manual and the toolkit from providers and from a community advisory board In Aim 3a the investigators will test the feasibility and acceptability of the intervention in a pilot randomized control trial RCT n60 The study team will also assess 1 changes in self-efficacy to attend cervical cancer-related healthcare appointments pre-post intervention 2 the proportion of women who attend a follow-up appointment and of those participants 3 the proportion of women who complete the next phase of treatment In Aim 3b the investigators will explore the feasibility of intervention implementation in the clinic and acceptability of the provider-level intervention components in qualitative interviews with providers clinic staff the interventionalists and other key stakeholders n10
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None