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 (2 sessions) and a provider toolkit, with the goal of increasing retention in care among WWH who are at heightened risk for cervical cancer. 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 at baseline, end of intervention, and three-months post-baseline, (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 and clinic staff (n\<10).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
The participant intervention will be two sessions, conducted in-person, coupled with text-based client navigation with women who received a recent Pap smear test. The intervention integrates (1) information to improve awareness of cervical cancer susceptibility and treatment, (2) brief cognitive behavioral therapy (CBT) skills to reduce individual-level barriers, (3) problem-solving to increase social support, and (4) patient navigation tools to mitigate clinic-level challenges.
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston University
Boston, Massachusetts, United States
MatCH Research Unit (MRU), a Division of the Wits Health Consortium, University of Witwatersrand
Durban, KwaZulu-Natal, South Africa
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 3-month follow-up. Feasibility of the implementation of the intervention will be explored in interviews with providers and clinic staff. To assess fidelity, each intervention session with be audio recorded; an assessor will review 20% of the session transcripts and determine whether all key session themes were addressed using checklists developed by the study team for the intervention.
Time frame: About 1 month after the start of intervention and at about 3 months after the start of the intervention
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.
Time frame: About 1 month after the start of intervention and at about 3 months after the start of the intervention
Self-efficacy to attend cervical cancer-related health care appointment
This will be measured by comparing change in scores from baseline, post-intervention, and the three-month follow-up visit between the intervention and ETAU groups. The maximum score is 35 and the minimum score is 7, with higher scores indicating more self-efficacy.
Time frame: At the start of the intervention, about 1 month after the start of intervention, and at about 3 months after the start of the intervention
Follow-up appointment attendance
This will be measured by comparing the proportions between intervention and ETAU groups at the end of the intervention and the three-month follow-up visit.
Time frame: about 1 month after the start of intervention and about 3 months after the start of the intervention
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