Cervical CancerNCT06182241
Identifying and Addressing Barriers to Retention in the Cervical Cancer Treatment Cascade Among Women With HIV in South Africa: Part 2
A study testing Retention in cervical cancer care intervention in people with Cervical Cancer and Hiv, run by Boston University Charles River Campus at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Hiv
- What is being tested?
- Retention in cervical cancer care intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 17 Nov 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Having a cervix
- Aged 18+
- Living with HIV
- Recent Pap smear test (within the past two months).
Who cannot join
- 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:
Show all 10Show fewer
- Younger than 18 years old
- HIV-negative
- No cervix/history of hysterectomy
- Unable to provide informed consent 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston University
Boston, Massachusetts, 02215
South Africa1 site
MatCH Research Unit (MRU), a Division of the Wits Health Consortium, University of Witwatersrand
Durban, KwaZulu-Natal, 4000
About this study
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).
- Conditions
- Cervical Cancer, Hiv
- Being tested
- Retention in cervical cancer care intervention
- Medical subject headings
- Uterine Cervical Neoplasms, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retention in cervical cancer care interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Participant intervention | Experimental | The intervention group will consist of two sessions, conducted in-person, coupled with text-based client navigation.The intervention group will complete three major assessments: baseline (T1), at the conclusion of the intervention (T2), and a three-month follow-up (T3). Until the follow-up assessment, the interventionist will send participants 2-3 SMS messages (one-way) per month. The content of these messages will be developed collaboratively between the participant and the interventionist during each session; messages could include reminders about follow-ups and/or prompts to use new skills and resources for navigating specific barriers. Receives: Behavioral: Retention in cervical cancer care intervention |
| Enhanced treatment as usual | No intervention | The enhanced treatment as usual (ETAU) group will receive treatment as usual, including being notified of their Pap results and instructed to set up a follow-up appointment if needed, as is typical in routine care. They will additionally receive an information sheet describing Pap smears and the relationship between HIV, HPV, and cervical cancer. The ETAU group will complete the T1, T2, and T3 assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: About 1 month after the start of intervention and at about 3 months after the start of the intervention
Secondary outcomes (2)
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.
Measured: 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.
Measured: about 1 month after the start of intervention and about 3 months after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start17 Nov 2025
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, Massachusetts General Hospital, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Amelia Stanton, PhD, Principal investigator, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182241
- Sponsor's protocol ID
- 7356E
- Other IDs
- R21CA279942
- Status last verified
- Oct 2026
- First submitted
- 30 Nov 2023
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying and Addressing Barriers to Retention in the Cervical Cancer Treatment Cascade Among Women With HIV in South Africa: Part 2
- ClinicalTrials.gov ID
- NCT06182241
- Acronym / sponsor ID
- 7356E
- Conditions
- Cervical Cancer, Hiv
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, Massachusetts General Hospital, National Cancer Institute (NCI)
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participant intervention | Experimental | Behavioral: Retention in cervical cancer care interventionThe intervention group will consist of two sessions, conducted in-person, coupled with text-based client navigation.The intervention group will complete three major assessments: baseline (T1), at the conclusion of the intervention (T2), and a three-month follow-up (T3). Until the follow-up assessment, the interventionist will send participants 2-3 SMS messages (one-way) per month. The content of these messages will be developed collaboratively between the participant and the interventionist during each session; messages could include reminders about follow-ups and/or prompts to use new skills and resources for navigating specific barriers. |
| Enhanced treatment as usual | No intervention | –The enhanced treatment as usual (ETAU) group will receive treatment as usual, including being notified of their Pap results and instructed to set up a follow-up appointment if needed, as is typical in routine care. They will additionally receive an information sheet describing Pap smears and the relationship between HIV, HPV, and cervical cancer. The ETAU group will complete the T1, T2, and T3 assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
- Having a cervix
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retention in cervical cancer care interventionThe 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. | Behavioural | Participant intervention |
Primary outcome
Feasibility of the intervention
Time frame: 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
Time frame: 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.
2 secondary outcomes
Self-efficacy to attend cervical cancer-related health care appointment
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
Time frame: about 1 month after the start of intervention and about 3 months after the start of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amelia Stanton, PhD principal investigator
Boston University Charles River Campus
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retention in cervical cancer care intervention in people with Cervical Cancer and Hiv, run by Boston University Charles River Campus at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention (time frame: About 1 month after the start of intervention and at about 3 months after the start of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.