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).
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).
Younger than 18 years old
HIV-negative
No cervix/history of hysterectomy
Recent normal or low-risk abnormal Pap results
Single group
Retention in cervical cancer care intervention
BehavioralAim 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.
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, clinic staff, interventionalists, and other relevant stakeholders.
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.
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.
Follow-up appointment attendance
This will be measured by comparing the proportions between intervention and TAU groups.
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Boston University Charles River Campus
Lead sponsor
University of Witwatersrand, South Africa
Collaborator
Massachusetts General Hospital
Collaborator
