Cervical Cancer, Hiv
Conditions
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 (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).
Interventions
BEHAVIORALRetention in cervical cancer care intervention
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.
Sponsors
Boston University Charles River Campus
University of Witwatersrand, South Africa
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aim 1 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. Aim 3 criteria: Inclusion Criteria: * Having a cervix * Aged 18+ * Living with HIV * Recent Pap smear test (within the past two months).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the intervention | About 1 month after the start of intervention and at about 3 months after the start 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. |
| Acceptability of the intervention | About 1 month after the start of intervention and at about 3 months after the start 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy to attend cervical cancer-related health care appointment | 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 | 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. |
| Follow-up appointment attendance | about 1 month after the start of intervention and about 3 months after the start of the intervention | 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. |
Countries
South Africa, United States
Contacts
PRINCIPAL_INVESTIGATORAmelia Stanton, PhD
Boston University Charles River Campus
Outcome results
None listed