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Retention Intervention for Cervical Cancer and HIV

N/A

Waitlist Available

Research Sponsored by Boston University Charles River Campus

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18+

Be older than 18 years old

Must not have

No cervix/history of hysterectomy

Younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start of the intervention and about 1-2 months after the start of intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to develop a new intervention to increase awareness and address the factors contributing to cervical cancer development in cisgender individuals with cervixes and women with HIV. The first part of the trial involves

Who is the study for?

This trial is for cisgender individuals with cervixes and women living with HIV in South Africa who have recently had a high-risk abnormal Pap smear. Participants should either have attended at least one follow-up visit or not yet attended any. The study aims to help them keep up with cervical cancer care appointments.

What is being tested?

The trial is developing an intervention that includes both patient- and provider-level components to improve retention in cervical cancer care among women with HIV. It involves interviews, creating a brief patient intervention, a provider toolkit, and testing these tools' feasibility and acceptability.

What are the potential side effects?

Since this study focuses on interventions related to attendance and awareness rather than medical treatments, traditional side effects are not applicable. However, participants may experience emotional or psychological impacts from discussing sensitive health issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a cervix due to a hysterectomy.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ about 1-2 months after the start of intervention and at about 7 months after the start of the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~about 1-2 months after the start of intervention and at about 7 months after the start of the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and about 1-2 months after the start of intervention and at about 7 months after the start of the intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of the intervention

Feasibility of the intervention

Secondary study objectives

Follow-up appointment attendance

Self-efficacy to attend cervical cancer-related health care appointment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Participant interventionExperimental Treatment1 Intervention

The intervention group will likely consist of one to two sessions, conducted in-person, coupled with text- or phone-based client navigation.The intervention group will complete three major assessments: baseline (T1), at the conclusion of the intervention (T2), and a six-month follow-up (T3). Until the follow-up assessment, the interventionist will send participants up to 6 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.

Group II: Treatment as usualActive Control1 Intervention

The treatment as usual (TAU) group will receive treatment as usual, including being notified of their abnormal Pap results via SMS and instructed to set up a follow-up appointment, as is typical in routine care. The TAU group will complete the T1 assessment and will complete T2 assessment two-months post-baseline.

0 / 3Eligibility criteria met