Identifying and Addressing Barriers to Retention in the Cervical Cancer Treatment Cascade Among Women With HIV in South Africa: Part 2

Hiv Clinical Trial

Official title:

Identifying and Addressing Barriers to Retention in the Cervical Cancer Treatment Cascade Among Women With HIV in South Africa: Part 2

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06182241
• Other study ID #: 7356E
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: January 2024
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Hiv
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Retention in cervical cancer care intervention
Aim 1 data will inform this intervention, however the participant intervention will likely be one or two sessions, conducted in-person, coupled with text- or phone-based client navigation with women who received abnormal high-risk Pap smear results. We anticipate that the intervention may integrate (1) information to improve awareness of cervical cancer susceptibility and treatment, (2) motivational interviewing to assess pros and cons of attending a follow-up appointment and completing treatment; (3) brief cognitive behavioral therapy (CBT) skills to reduce individual-level barriers, (4) problem-solving to increase social support, and (5) patient navigation tools to mitigate clinic-level challenges.

Locations

Country	Name	City	State
South Africa	MatCH Research Unit (MRU), a Division of the Wits Health Consortium, University of Witwatersrand	Durban	KwaZulu-Natal
United States	Boston University	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston University Charles River Campus	Massachusetts General Hospital, University of Witwatersrand, South Africa

Countries where clinical trial is conducted

United States,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the intervention	Feasibility will be demonstrated if all three are met by participants: (1) 50% of participants who are approached choose to enroll; (2) 70% of participants complete the intervention; and (3) 60% complete the 6-month follow-up. Feasibility of the implementation of the intervention will be explored in interviews with providers, clinic staff, interventionalists, and other relevant stakeholders.	About 1-2 months after the start of intervention and at about 7 months after the start of the intervention
Primary	Acceptability of the intervention	Acceptability will be measured using the seven component constructs of the acceptability of health care interventions framework using a five-point Likert style scale. The seven components include affective attitude (i.e., how an individual feels about the intervention), burden, ethicality (i.e., the extent to which the intervention aligns with one's value system), intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy. Acceptability will be demonstrated if, on average, at least 75% of the participants rate five or more of the items on the eight-item Acceptability of Healthcare Interventions Questionnaire with a 4 or a 5 on the Likert-style scale. Acceptability of the intervention will also be explored in interviews with providers, clinic staff, interventionalists, and other relevant stakeholders.	About 1-2 months after the start of intervention and at about 7 months after the start of the intervention
Secondary	Self-efficacy to attend cervical cancer-related health care appointment	This will be measured by comparing change scores from baseline to post-intervention between the intervention and TAU groups.	Start of the intervention and about 1-2 months after the start of intervention
Secondary	Follow-up appointment attendance	This will be measured by comparing the proportions between intervention and TAU groups.	About 7 months after the start of the intervention