Support for Women with HIV and Cervical Cancer Risk
Identifying and Addressing Barriers to Retention in the Cervical Cancer Treatment Cascade Among Women With HIV in South Africa: Part 2
Recruiting
N/AInterventional Study
Cervical CancerHiv
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Boston University Charles River Campus · Other
Who this trial is looking for
This trial is looking for women over 18 who are living with HIV and have had recent high-risk abnormal Pap smear results. Participants will help develop and test a new support program to improve attendance at follow-up healthcare appointments for cervical cancer care.
Are You a Good Fit for This Trial?
You may be able to join if
I have a cervix
I am 18 years or older
I am living with HIV
I have had recent high-risk abnormal Pap results within the last month
You may not be able to join if
I am younger than 18 years old
I am HIV-negative
I do not have a cervix or have had a hysterectomy
I have had recent normal or low-risk abnormal Pap results
I am unable to provide informed consent or assent in English or isiZulu
I have a significant psychiatric illness that could interfere with my participation
I have health conditions that make it difficult for me to travel to the clinic
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 an…
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).
Trial Locations
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City
State
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Status
Eligibility 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/…
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.
Contacts
No contact information available.
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