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

Study Overview
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Brief Summary
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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 people with cervixes and women with HIV (WWH). In Aim 1a, the research team 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, via qualitative interviews with WWH who have had a high-risk abnormal Pap smear in the past six months and have either attended at least one follow-up visit (n<15) or have not yet attended a follow-up visit (n<15). In Aim 1b, the research team 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 research team will leverage the Aim 1 data, develop a brief 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 investigators will seek feedback on the manual and the toolkit from providers and from a community advisory board. In Aim 3, the research team will test the feasibility and acceptability of the intervention in an open pilot study (n=8-10). The investigators 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.

Official Title
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Identifying and Addressing Barriers to Retention in the Cervical Cancer Treatment Cascade Among Women With HIV in South Africa

Conditions
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Hiv, Cervical Cancer

Intervention / Treatment
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* Behavioral: Retention in cervical cancer care intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participant Intervention<br> | Behavioral: Retention in cervical cancer care intervention<br>* 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. There will be three major assessments: baseline, at the conclusion of the intervention, and a three-month follow-up. At the end of what we anticipate will be the second session, acceptability of the intervention will be assessed. Until the follow-up assessment, the interventionist will send participants two to three SMS messages (one-way) per month. The content of these messages will be developed collaboratively between the participant and the interventionist during the second session; messages could include reminders about follow-ups and/or prompts to use new skills and resources for navigating specific barriers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | About 1 month after the start of intervention and at about 4 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. | About 1 month after the start of intervention and at about 4 months after the start of the intervention | 
| Feasibility of implementing the intervention in the clinic and using the provider toolkit | Feasibility of implementing the intervention in the clinic and using the provider toolkit will be explored in individual qualitative interviews with providers and clinic staff after the open pilot has ended. | About 4 months after the start of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-efficacy to attend a follow-up appointment | The two items are: (1) How confident are you that you will attend your follow up appointment? The answer choices are 0-not confident, 1-somewhat confident, 2-confident, 3-very confident; (2) How likely are you to attend your follow-up appointment? The answer choices are 0-not likely, 1-somewhat likely, 2-likely, 3-very likely. | Start of the intervention and about 1 month after the start of intervention | 
| Proportion of women who attend a follow-up appointment |  | About 4 months after the start of the intervention | 
| Proportion of women who complete the next phase of treatment |  | About 4 months after the start of the intervention |