HIVIHSNCT07446764
Integrated Health Services (IHS): A Structural Intervention to Improve HIV/STI Screening and PrEP Navigation in Primary Care
A study testing Integrated HIV/STI Testing and PrEP Navigation Model in people with HIV and STDs, run by My Brother's Keeper, Inc. at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether integrating routine, opt-out HIV and STI testing and pre-exposure prophylaxis (PrEP) navigation into primary care increases use of these services among adults ages 18 to 45 receiving care at Federally Qualified Health Centers in Mississippi. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- What is being tested?
- Integrated HIV/STI Testing and PrEP Navigation Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2027to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults ages 18 to 45 years.
- Receiving primary care services at participating Federally Qualified Health Center (FQHC) clinics in Canton or Yazoo City, Mississippi.
- Able to understand and read English (for participation in surveys and interviews).
- For staff key informants: current clinical, administrative, or support role at a participating FQHC site with responsibilities related to primary care, HIV/STI services, or care coordination.
Who cannot join
- Younger than 18 years or older than 45 years.
- Critically ill, psychiatrically unstable, or lacking capacity to provide informed consent for research participation.
- Unable to understand English for consent and survey/interview procedures.
- For staff key informants: unable or unwilling to provide informed consent for interviews or surveys.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
My Brother's Keeper, Inc.
Ridgeland, Mississippi, 39157
June a Gipson, PhD, 769-216-2455 ext. 101, jgipson@mbk-inc.org
Edna Lampkin, Pharm D., 7692162455 ext. 216, elampkin@mbk-inc.org
About this study
The goal of this clinical trial is to learn whether integrating routine, opt-out HIV and STI testing and pre-exposure prophylaxis (PrEP) navigation into primary care increases use of these services among adults ages 18 to 45 receiving care at Federally Qualified Health Centers in Mississippi. The main questions it aims to answer are:
- Does the integrated model increase HIV and STI testing compared with standard care?
- Does the integrated model increase PrEP navigation activity for eligible patients?
- How do patients and clinic staff experience the integrated model in terms of satisfaction, comfort discussing sexual health, and feasibility in daily workflows?
Read more
Researchers will compare a standard-care period to a period when the integrated model is in place to see if the integrated model improves service use and patient experience.
Participants will:
- Receive usual primary care, with HIV/STI testing and PrEP discussions offered as a routine, opt-out part of care during the integrated period
- Be invited, if eligible, to complete a brief survey about their clinic experience
- For staff, be invited to take part in a short survey or interview about clinic workflows and the integrated model
Read the detailed description
This is a quasi-experimental, mixed-methods implementation study designed to evaluate an integrated sexual and reproductive health (SRH) model that embeds routine, opt-out HIV and sexually transmitted infection (STI) testing and pre-exposure prophylaxis (PrEP) navigation into primary care workflows at two Federally Qualified Health Centers (FQHCs) in Canton and Yazoo City, Mississippi. The study focuses on adults ages 18-45 receiving primary care at participating clinics, a population experiencing high HIV/STI burden and structural barriers to SRH services, including limited routine testing, low PrEP uptake, and fragmented referral pathways. The intervention is informed by the Comprehensive Theory of Integration and aims to normalize HIV/STI testing as part of routine care while strengthening PrEP navigation and care coordination within existing clinic infrastructure.
The intervention operates at the clinic and workflow level rather than at the level of individual randomization. During the standard-care period, HIV/STI testing and PrEP discussions occur based on provider discretion or patient request, supported by existing electronic health record (EHR) prompts. During the integrated-care period, the study implements standing orders for nurses and peer navigators to initiate HIV tests, guideline-aligned STI tests, and PrEP navigation for eligible patients; EHR prompts and templates that cue providers to offer testing and PrEP in an opt-out manner; embedded peer navigation and daily team huddles to support linkage and follow-up; and training and technical assistance to promote culturally responsive, stigma-informed care. These changes are designed to be feasible within typical FQHC staffing and technology constraints.
The study uses a 24-month pre-post design, with a 12-month standard-care phase followed by a 12-month integrated-care phase. Primary quantitative data will be derived from de-identified or limited EHR extracts containing variables such as age, sex, race/ethnicity, visit type, HIV/STI test ordering and completion, PrEP offers and navigation steps, and documented declinations. Additional quantitative data will be collected through brief patient surveys assessing visit experience, satisfaction, comfort discussing sexual health, perceptions of opt-out testing, and experiences with PrEP discussions and navigation. Qualitative data will be obtained via semi-structured key-informant interviews and surveys with medical providers, nurses/medical assistants, patient navigators and community health workers, and clinic administrators, as well as interviews with a subset of patients, to explore implementation processes, barriers and facilitators, perceived impact, and sustainability.
No experimental drugs or devices are used, and all HIV/STI testing and PrEP services adhere to current clinical guidelines as part of routine care. The research procedures consist of (1) implementing and monitoring the integrated workflow; (2) abstracting EHR data under an IRB-approved waiver of consent and, where applicable, HIPAA authorization; and (3) collecting survey and interview data from patients and staff under informed consent. The primary implementation outcome is change in HIV/STI test uptake among adults ages 18-45 between the standard-care and integrated-care periods. Secondary outcomes include changes in PrEP navigation activity, patient-reported satisfaction and comfort discussing sexual health, provider adoption and fidelity to integrated SRH workflows, and feasibility and acceptability of the intervention from staff and patient perspectives. Analytic plans include pre-post comparisons of service uptake and navigation metrics, as well as thematic analysis of qualitative data to identify contextual factors (e.g., staffing, workflow, stigma, policy environment) that influence successful integration and scalability of the model in high-need FQHC settings.
- Being tested
- Integrated HIV/STI Testing and PrEP Navigation Model
- Keywords
- HIV/AIDS, Sexual transmitted diseases, STDs, STIs, PrEP, Healthcare, Integrated healthcare, Sexual Health, Reproductive Health, Practice Guidelines, Intervention, Health Care Availability, Structural Determinants
- Medical subject headings
- Sexually Transmitted Diseases, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated HIV/STI Testing and PrEP Navigation ModelBehavioural
Clinic-level implementation of an integrated sexual and reproductive health model that embeds routine, opt-out HIV and sexually transmitted infection (STI) testing and pre-exposure prophylaxis (PrEP) navigation into primary care at Federally Qualified Health Centers. The intervention includes: (1) standing orders for nurses and peer navigators to initiate HIV/STI testing and PrEP navigation for eligible adults ages 18-45; (2) enhanced electronic health record prompts and templates to support opt-out testing and documentation of offers, completions, and declinations; (3) embedded peer navigation and daily team huddles to coordinate linkage and follow-up; and (4) training and technical assistance for clinic staff on workflows, cultural responsiveness, and stigma-reduction related to sexual health and PrEP.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Usual care delivered before implementation of the Integrated Health Services (IHS) model. HIV/STI testing and PrEP navigation occur at provider discretion without standardized workflows or EHR prompts. This represents the 12-month pre-intervention period. |
| Integrated HIV/STI and PrEP Care | Experimental | Care delivered during the 12-month intervention period using the Integrated Health Services (IHS) model, which incorporates routine opt-out HIV/STI screening, standing orders, EHR prompts, and standardized PrEP navigation workflows Receives: Behavioral: Integrated HIV/STI Testing and PrEP Navigation Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Testing Uptake
Proportion of primary care visits among adults ages 18-45 at participating FQHC clinics with an HIV test completed (numerator: visits with HIV test completed; denominator: eligible visits for adults 18-45), comparing the standard-care period to the integrated-care period using electronic health record data.
Measured: 12 months during standard-care period and 12 months during integrated-care period
Secondary outcomes (5)
STI Testing Uptake
Proportion of primary care visits among adults ages 18-45 with at least one guideline-aligned STI test (e.g., chlamydia, gonorrhea, syphilis) completed, comparing the standard-care period to the integrated-care period using electronic health record data.
Measured: 12 months during standard-care period and 12 months during integrated-care period
PrEP Navigation Activity
Proportion of eligible adult patients ages 18-45 with a documented PrEP offer and/or navigation step (e.g., referral, navigation contact, PrEP prescription) during primary care visits, comparing standard-care and integrated-care periods using electronic health record data.
Measured: 12 months during standard-care period and 12 months during integrated-care period
Patient Satisfaction With Integrated Care
Mean composite score on the patient satisfaction survey completed by adults ages 18-45 after a primary care visit during the integrated care period.
Measured: Within 7 days of an index primary care visit during the integrated-care period
Staff Feasibility Rating
Mean feasibility rating score from staff surveys assessing feasibility of the integrated-care workflows.
Measured: At 6 and 12 months after initiation of the integrated-care period
Staff Acceptability Rating
Mean acceptability rating score from staff surveys evaluating the acceptability of integrated workflows, including perceived usefulness, appropriateness, and value among providers, nurses/medical assistants, navigators, and administrators.
Measured: Assessed at 6 months and 12 months after initiation of the integrated care period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Feb 2027 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- My Brother's Keeper, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Mississippi, University of Mississippi Medical Center
- Responsible party
- Principal investigator, June Gipson, My Brother's Keeper, Inc.
- Investigators
- June A Gipson, PhD, Principal investigator, My Brother's Keeper, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446764
- Sponsor's protocol ID
- MBK-IHS-01
- Other IDs
- 3OT2OD035877-01S2
- Acronym
- IHS
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the primary and secondary outcome results (selected EHR variables for adults ages 18-45 and de-identified patient and staff survey responses) will be shared. No direct identifiers or HIPAA-defined identifiers will be included, and small cells will be handled to reduce re-identification risk. IPD will be available within 12 months after publication of the main study findings and for at least 5 years thereafter. Data will be shared with qualified researchers who have a scientifically sound proposal, appropriate ethics/IRB approval, and a signed data use agreement with My Brother's Keeper, Inc. and partner clinics. Data will be provided via secure, encrypted transfer or a controlled-access repository.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Health Services (IHS): A Structural Intervention to Improve HIV/STI Screening and PrEP Navigation in Primary Care
- ClinicalTrials.gov ID
- NCT07446764
- Acronym / sponsor ID
- IHS / MBK-IHS-01
- Keywords
- HIV/AIDS, Sexual transmitted diseases, STDs, STIs, PrEP, Healthcare, Integrated healthcare, Sexual Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- My Brother's Keeper, Inc.University, hospital or other
- Collaborators
- University of Southern Mississippi, University of Mississippi Medical Center
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 3 Mar 2026 (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 goal of this clinical trial is to learn whether integrating routine, opt-out HIV and STI testing and pre-exposure prophylaxis (PrEP) navigation into primary care increases use of these services among adults ages 18 to 45 receiving care at Federally Qualified Health Centers in Mississippi. The main questions it aims to answer are:
- Does the integrated model increase HIV and STI testing compared with standard care?
- Does the integrated model increase PrEP navigation activity for eligible patients?
- How do patients and clinic staff experience the integrated model in terms of satisfaction, comfort discussing sexual health, and feasibility in daily workflows?
Researchers will compare a standard-care period to a period when the integrated model is in place to see if the integrated model improves service use and patient experience.
Participants will:
- Receive usual primary care, with HIV/STI testing and PrEP discussions offered as a routine, opt-out part of care during the integrated period
- Be invited, if eligible, to complete a brief survey about their clinic experience
- For staff, be invited to take part in a short survey or interview about clinic workflows and the integrated model
Detailed description
This is a quasi-experimental, mixed-methods implementation study designed to evaluate an integrated sexual and reproductive health (SRH) model that embeds routine, opt-out HIV and sexually transmitted infection (STI) testing and pre-exposure prophylaxis (PrEP) navigation into primary care workflows at two Federally Qualified Health Centers (FQHCs) in Canton and Yazoo City, Mississippi. The study focuses on adults ages 18-45 receiving primary care at participating clinics, a population experiencing high HIV/STI burden and structural barriers to SRH services, including limited routine testing, low PrEP uptake, and fragmented referral pathways. The intervention is informed by the Comprehensive Theory of Integration and aims to normalize HIV/STI testing as part of routine care while strengthening PrEP navigation and care coordination within existing clinic infrastructure.
The intervention operates at the clinic and workflow level rather than at the level of individual randomization. During the standard-care period, HIV/STI testing and PrEP discussions occur based on provider discretion or patient request, supported by existing electronic health record (EHR) prompts. During the integrated-care period, the study implements standing orders for nurses and peer navigators to initiate HIV tests, guideline-aligned STI tests, and PrEP navigation for eligible patients; EHR prompts and templates that cue providers to offer testing and PrEP in an opt-out manner; embedded peer navigation and daily team huddles to support linkage and follow-up; and training and technical assistance to promote culturally responsive, stigma-informed care. These changes are designed to be feasible within typical FQHC staffing and technology constraints.
The study uses a 24-month pre-post design, with a 12-month standard-care phase followed by a 12-month integrated-care phase. Primary quantitative data will be derived from de-identified or limited EHR extracts containing variables such as age, sex, race/ethnicity, visit type, HIV/STI test ordering and completion, PrEP offers and navigation steps, and documented declinations. Additional quantitative data will be collected through brief patient surveys assessing visit experience, satisfaction, comfort discussing sexual health, perceptions of opt-out testing, and experiences with PrEP discussions and navigation. Qualitative data will be obtained via semi-structured key-informant interviews and surveys with medical providers, nurses/medical assistants, patient navigators and community health workers, and clinic administrators, as well as interviews with a subset of patients, to explore implementation processes, barriers and facilitators, perceived impact, and sustainability.
No experimental drugs or devices are used, and all HIV/STI testing and PrEP services adhere to current clinical guidelines as part of routine care. The research procedures consist of (1) implementing and monitoring the integrated workflow; (2) abstracting EHR data under an IRB-approved waiver of consent and, where applicable, HIPAA authorization; and (3) collecting survey and interview data from patients and staff under informed consent. The primary implementation outcome is change in HIV/STI test uptake among adults ages 18-45 between the standard-care and integrated-care periods. Secondary outcomes include changes in PrEP navigation activity, patient-reported satisfaction and comfort discussing sexual health, provider adoption and fidelity to integrated SRH workflows, and feasibility and acceptability of the intervention from staff and patient perspectives. Analytic plans include pre-post comparisons of service uptake and navigation metrics, as well as thematic analysis of qualitative data to identify contextual factors (e.g., staffing, workflow, stigma, policy environment) that influence successful integration and scalability of the model in high-need FQHC settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Usual care delivered before implementation of the Integrated Health Services (IHS) model. HIV/STI testing and PrEP navigation occur at provider discretion without standardized workflows or EHR prompts. This represents the 12-month pre-intervention period. |
| Integrated HIV/STI and PrEP Care | Experimental | Behavioral: Integrated HIV/STI Testing and PrEP Navigation ModelCare delivered during the 12-month intervention period using the Integrated Health Services (IHS) model, which incorporates routine opt-out HIV/STI screening, standing orders, EHR prompts, and standardized PrEP navigation workflows |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults ages 18 to 45 years.
- Receiving primary care services at participating Federally Qualified Health Center (FQHC) clinics in Canton or Yazoo City, Mississippi.
- Able to understand and read English (for participation in surveys and interviews).
- For staff key informants: current clinical, administrative, or support role at a participating FQHC site with responsibilities related to primary care, HIV/STI services, or care coordination.
Key exclusion criteria (4 listed)
- Younger than 18 years or older than 45 years.
- Critically ill, psychiatrically unstable, or lacking capacity to provide informed consent for research participation.
- Unable to understand English for consent and survey/interview procedures.
- For staff key informants: unable or unwilling to provide informed consent for interviews or surveys.
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 |
|---|---|---|
| Integrated HIV/STI Testing and PrEP Navigation ModelClinic-level implementation of an integrated sexual and reproductive health model that embeds routine, opt-out HIV and sexually transmitted infection (STI) testing and pre-exposure prophylaxis (PrEP) navigation into primary care at Federally Qualified Health Centers. The intervention includes: (1) standing orders for nurses and peer navigators to initiate HIV/STI testing and PrEP navigation for eligible adults ages 18-45; (2) enhanced electronic health record prompts and templates to support opt-out testing and documentation of offers, completions, and declinations; (3) embedded peer navigation and daily team huddles to coordinate linkage and follow-up; and (4) training and technical assistance for clinic staff on workflows, cultural responsiveness, and stigma-reduction related to sexual health and PrEP. | Behavioural | Integrated HIV/STI and PrEP Care |
Primary outcome
HIV Testing Uptake
Time frame: 12 months during standard-care period and 12 months during integrated-care period
Proportion of primary care visits among adults ages 18-45 at participating FQHC clinics with an HIV test completed (numerator: visits with HIV test completed; denominator: eligible visits for adults 18-45), comparing the standard-care period to the integrated-care period using electronic health record data.
5 secondary outcomes
STI Testing Uptake
Time frame: 12 months during standard-care period and 12 months during integrated-care period
PrEP Navigation Activity
Time frame: 12 months during standard-care period and 12 months during integrated-care period
Patient Satisfaction With Integrated Care
Time frame: Within 7 days of an index primary care visit during the integrated-care period
Staff Feasibility Rating
Time frame: At 6 and 12 months after initiation of the integrated-care period
Staff Acceptability Rating
Time frame: Assessed at 6 months and 12 months after initiation of the integrated care period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the primary and secondary outcome results (selected EHR variables for adults ages 18-45 and de-identified patient and staff survey responses) will be shared. No direct identifiers or HIPAA-defined identifiers will be included, and small cells will be handled to reduce re-identification risk. IPD will be available within 12 months after publication of the main study findings and for at least 5 years thereafter. Data will be shared with qualified researchers who have a scientifically sound proposal, appropriate ethics/IRB approval, and a signed data use agreement with My Brother's Keeper, Inc. and partner clinics. Data will be provided via secure, encrypted transfer or a controlled-access repository.
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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.
June A Gipson, PhD principal investigator
My Brother's Keeper, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated HIV/STI Testing and PrEP Navigation Model in people with HIV and STDs, run by My Brother's Keeper, Inc. at 1 site in United States.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact June A Gipson, PhD (769-216-2455 ext. 101, jgipson@mbk-inc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Testing Uptake (time frame: 12 months during standard-care period and 12 months during integrated-care period). 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 3 Mar 2026.