Clinical trial NCT06182241: Identifying and Addressing Barriers to Retention in the Cervical Cancer Treatment Cascade Among Women with HIV in South Africa: Part 2
Official title: Identifying and Addressing Barriers to Retention in the Cervical Cancer Treatment Cascade Among Women with HIV in South Africa: Part 2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Hiv
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: University of Witwatersrand, South Africa
name: Massachusetts General Hospital
First posted: 2023-12-26
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (n\<10) or have not yet attended a follow-up visit (n\<10). 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 (n\<8). 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) (n\<60). 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 (n\<10).


Eligibility criteria: Inclusion Criteria:

* Having a cervix
* Aged 18+
* Living with HIV
* Recent high-risk abnormal Pap results within the last month (if needed, we may increase the range by up to 6 months to ensure that we meet our targets).

Exclusion Criteria:

* Younger than 18 years old
* HIV-negative
* No cervix/history of hysterectomy
* Recent normal or low-risk abnormal Pap results
* Unable to provide informed consent or assent in English or isiZulu and/or have a significant psychiatric illness (e.g., active psychotic disorder or untreated bipolar disorder) that could interfere with participation will be excluded. Potential participants will also be asked if they have any health conditions that make it difficult for them to travel to the clinic.

Primary outcomes:
measure: Feasibility of the intervention
timeFrame: About 1-2 months after the start of intervention and at about 7 months after the start of the intervention
measure: Acceptability of the intervention
timeFrame: About 1-2 months after the start of intervention and at about 7 months after the start of the intervention
Secondary outcomes:
measure: Self-efficacy to attend cervical cancer-related health care appointment
timeFrame: Start of the intervention and about 1-2 months after the start of intervention
measure: Follow-up appointment attendance
timeFrame: About 7 months after the start of the intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Durban
country: South Africa
facility: MatCH Research Unit (MRU), a Division of the Wits Health Consortium, University of Witwatersrand
state: KwaZulu-Natal
Study officials:
References: