Project Introduction

From 2014 through 2019, the incidences of bacterial sexually transmitted infections (STIs) Chlamydia trachomatis, Neisseria gonorrhoeae, and syphilis increased each year in the United States. In response, the US Department of Health and Human Services, Health Resources and Services Administration (HRSA) HIV/AIDS Bureau, and Bureau of Primary Health Care (BPHC) funded a 3-year (2018–2021) Special Projects of National Significance (SPNS) cooperative agreement, Improving Sexually Transmitted Infection Screening and Treatment among People Living with or at Risk for HIV.

The purpose of this initiative was to evaluate the implementation of evidence-based interventions to improve routine screening, testing, and treatment of bacterial STIs among low-income people with or at risk of HIV. The François-Xavier Bagnoud Center, Rutgers School of Nursing, partnered with nine Ryan White HIV/AIDS Program (RWHAP)-funded clinics, of which two were also funded through the BPHC Health Center Program, to complete this project.

The nine clinics included three from each of three US jurisdictions with higher-than-national-average incidence rates of C. trachomatis, N. gonorrhoeae, syphilis, and HIV. The three jurisdictions, FL, LA, and Washington, DC, each had a jurisdictional convener site located in the region to assist with implementation, evaluation, and dissemination of results and best practices in that jurisdiction (Table 1).

Table 1.

Jurisdictional Conveners and Clinical Demonstration Sites

Role	Organization	Location
Convener	University of Florida College of Medicine	Gainesville, FL
Clinical demonstration site	Alachua County, Florida Department of Health	Gainesville, FL
Clinical demonstration site	Bay County, Florida Department of Health	Panama City, FL
Clinical demonstration site	Orange County, Florida Department of Health	Orlando, FL
Convener	Louisiana University Health Science Center	New Orleans, LA
Clinical demonstration site	CareSouth Medical and Dental	Baton Rouge, LA
Clinical demonstration site	Louisiana University Health Science Center, Viral Disease Clinic	Shreveport, LA
Clinical demonstration site	Southwest Louisiana AIDS Council Comprehensive Care Center	Lake Charles, LA
Convener	Howard University College of Medicine	Washington, DC
Clinical demonstration site	Andromeda Transcultural Health	Washington, DC
Clinical demonstration site	Family Medical & Counseling Service	Washington, DC
Clinical demonstration site	Howard University Center for Infectious Diseases and Research Clinic	Washington, DC

In the first year of the 3-year funding cycle, a mixed-methods needs assessment was conducted with each of the nine clinics to identify which of multiple evidence-based interventions identified by a HRSA-appointed technical experts panel would be recommended for implementation in each clinic. The HRSA-identified interventions were categorized as training, clinical, nonclinical, and system level. Since the findings across all clinics were similar, the same interventions were recommended for all nine clinics.

These interventions included provider training (training), an audio computer-assisted self-interview (ACASI) sexual history (nonclinical), patient self-collection of C. trachomatis/N. gonorrhoeae nucleic acid amplification tests (NAATs) at urogenital and extragenital sites (clinical), and sexual and gender minority clinic welcoming measures (nonclinical), and provider detailing (system level).

• The provider training consisted of four virtual training sessions over a 1-year period customized to clinicians' needs, but all clinical team members were encouraged to attend. The topics were selected based on needs assessment findings.

• The ACASI sexual history is an interval sexual behavior history along with questions related to gender, sexual orientation identity, and STIs symptoms (Table 2). The sexual history produced a summary page, which was either printed out or entered into the electronic health record (EHR), indicating which STI tests were recommended based on answers provided in the symptoms section and/or the sexual behavior risk factors questions. This summary sheet then could be used by clinical staff to order recommended STI tests using a standing order created for this purpose (i.e., at a laboratory visit without a provider visit) or by the clinical provider seeing the patient at that visit (Fig. 1).

FIG. 1.

Sexual history summary report example.

Table 2.

Sexual History Questions

What is your current gender identity? (Check one) □ Male □ Female □ Transgender male/transgender man/female-to-male □ Transgender female/transgender woman/male-to-female □ Gender nonbinary, genderqueer □ Additional gender category specify: ___________________ □ Choose not to disclose

What sex were you assigned at birth on your original birth certificate? (Check one) □ Male □ Female □ Choose not to disclose

What is your sexual orientation identity? (Check one) □ Straight or heterosexual □ Lesbian or gay or same-gender loving □ Bisexual or pansexual □ Something else □ Do not know □ Choose not to disclose

1. Since your last health care provider visit, have you had: a. Any discharge or mucus of any color coming from your penis □ No □ Yes □ Not applicable b. Any discharge or mucus of any color coming from your vagina □ No □ Yes □ Not applicable c. Any discharge or mucus of any color coming from your rectum or anus or butt □ No □ Yes d. Any burning or pain when you urinate or pee □ No □ Yes e. A rash anywhere on your body □ No □ Yes f. A “sore,” even if it does not hurt, on your penis □ No □ Yes □ Not applicable g. A “sore,” even if it does not hurt, on or inside your vagina □ No □ Yes □ Not applicable h. A “sore,” even if it does not hurt, in your mouth □ No □ Yes i. A sore throat □ No □ Yes j. Swollen, painful lymph nodes or “glands” in your neck □ No □ Yes k. Swollen, painful lymph nodes or “glands” in your groin □ No □ Yes

2. Since your last health care provider visit, have you had any sex including oral or vaginal or rectal? □ No (If “no,” skip to question 16) □ Yes

3. Since your last health care provider visit, have you had any sex with someone with a penis? □ No □ Yes

4. How many different people? _________________

5. Were any of them new sexual partners since your last health care provider visit? □ No □ Yes

6. Since your last health care provider visit, have you had sex with someone with a vagina? □ No □ Yes

7. How many different people? __________________

8. Were any of them new sexual partners since your last health care provider visit? □ No □ Yes

9. Since your last health care provider visit, have you had any oral or mouth sex? □ No □ Yes

10. Since your last health care provider visit, which types of oral or mouth sex have you had? (Check all that apply) □ Partner's mouth to your penis or vagina □ Partner's mouth to your anus or butt □ Your mouth to your partner's penis or vagina □ Your mouth to your partner's anus or butt

11. Since your last health care provider visit, have you had any vaginal sex, that is someone's penis in your vagina or your penis in someone's vagina? □ No □ Yes

12. Since your last health care provider visit, have you had any anal or butt sex? □ No □ Yes

13. Since your last health care provider visit, which types of anal or butt sex have you had? (Check all that apply) □ Anal insertive, that is your penis in your partner's rectum or butt □ Anal receptive, that is your partner's penis in your rectum or butt

14. Since your last health care provider visit, have you used alcohol before having sex? □ No □ Yes

15. Since your last health care provider visit, have you used marijuana or any other drug(s) before having sex? □ No □ Yes

16. Since your last health care provider visit, have you received or given money or housing or food for sex? □ No □ Yes

17. Since your last health care provider visit, with how many different sexual partners did you receive or give money or housing or food for sex? _________________

18. Has your current or past partner or partners been diagnosed or treated for a sexually transmitted infection since your last health care provider visit? □ No □ Yes □ Unsure

19. What was the infection and treatment? (Check all that apply) □ Partner got a shot and took some pills for gonorrhea □ Partner took some pills only for chlamydia □ Partner got a shot(s) once for syphilis □ Partner got shot(s) each week for 3 weeks for syphilis □ Partner got some pills for another infection □ I do not know what the infection or treatment was

20. If you have only one sexual partner, does this partner have sex with other people in addition to you? □ No □ Yes □ Unsure □ Not applicable

21. Since you were last seen in the clinic, have you used a male condom? □ No □ Yes

22. For what kinds of sex did you use a male condom? (Check all that apply) □ Oral sex □ Vaginal sex □ Rectal sex □ Not applicable

23. Since you were last seen in the clinic, have you used a female condom? □ No □ Yes

24. For what kinds of sex did you use a female condom? (Check all that apply) □ Oral sex □ Vaginal sex □ Rectal sex □ Not applicable

25. Since you were last seen in the clinic, have you used a dental dam? □ No □ Yes

*26. Do any of the following apply to you since your last clinic visit? (Check all that apply) *Question 26 is only for patients with HIV □ I keep an undetectable HIV viral load with antiretroviral therapy to prevent my partner(s) from getting HIV □ My partner uses PrEP □ My partner uses PEP when needed □ None of the these

**27. Since your last clinic visit, have you used any of the following measures to prevent HIV infection? (Check all that apply) **Question 27 is only for patients without HIV but at risk for HIV infection □ I use PrEP and take it everyday □ I use PrEP but do not take it everyday □ I have used PEP □ I have had condomless sex with a partner with HIV, but that partner has an undetectable HIV viral load □ None of these

28. If you need a test for gonorrhea and chlamydia in your throat, which would you prefer? □ I would prefer to swab my own throat after being told how □ I would prefer a health care team member swab my throat

29. If you need to test your penis or vagina for gonorrhea and chlamydia, which would you prefer? □ I would prefer to collect the swab myself after being told how □ I would prefer to urinate or pee in a cup □ I would prefer that a health care team member collect the swab

30. If you need a test for gonorrhea and chlamydia from your rectum or butt, which would you prefer? □ I would prefer to collect the swab myself after being told how □ I would prefer that a health care team member collects the swab

PEP, post-exposure prophylaxis; PrEP, pre-exposure prophylaxis.

• The patient self-collection of urogenital and extragenital site specimens for C. trachomatis/N. gonorrhoeae NAATs was offered to all patients along with instructions of how to do self-collection and posters on how to self-collect pharyngeal, rectal, and vaginal swabs (posted in patient bathroom or clinic room where specimen collection is discussed).

• Lesbian, gay, bisexual, transgender, queer, and other sexual and gender minority individuals (LGBTQ+) “welcoming” clinical space indicators were implemented in each clinic. Twelve welcoming space indicators (Table 3) were identified to promote LGBTQ+ inclusiveness and safety, and each clinic was to implement at least 10 of the 12 indicators. Two of the indicators, an all-gender patient restroom and a community advisory board to include sexual minority and gender minority members, were not required if not already in place due to cost and organizational capacity to put into place.

Table 3.

LGBTQ+ Welcoming Clinical Space Indicators

A gender identity, gender expression, and sexual orientation nondiscrimination policy clearly displayed

Acknowledgment of LGBTQ awareness and recognition days/events (e.g., transgender day of remembrance, LGBTQ pride)

All staff training on gender identity diversity and sexual orientation (>1 staff member from each clinic)

Clinic registration/intake form has a question for patient name and pronoun (in addition to legal documentation such as those with birth name)

Community advisory board with sexual and gender minority members

Community-based affiliations with sexual/gender minority supportive organizations—flyers or cards in waiting room with information about these organizations

Gender and sexual minority inclusive educational materials (gender diverse persons and same-gender couples)

Gender-neutral bathroom(s)

History taking includes assigned sex at birth, and current gender identity inclusive of nonbinary identities

LGBTQ flag (red, orange, yellow, green, blue, purple) in waiting room

Transgender flag (blue, pink, white, pink, blue) or symbol in waiting room

Visible gender and sexual minority inclusiveness in waiting room materials (magazines, posters, flyers)

• The provider detailing intervention was implemented by the jurisdictional conveners. The purpose of this system level intervention was to coalesce, align, and strengthen collaboration between HIV health care providers to educate and promote adoption of routine bacterial STI screening, testing, treatment, and follow-up of patients with and/or at-risk of HIV. Each convener recruited an RWHAP- or BPHC-funded site that demonstrated need for increased STI screening, testing, and treatment as evidenced by not implementing project interventions used in this project. Each recruited site completed a Pre-Provider Detailing Visit: Brief Provider Evaluation and a Post-Provider Detailing Visit: Brief Provider Evaluation.

The training, clinical, and nonclinical interventions were to be implemented at each of the nine clinics simultaneously. However, due to the COVID-19 pandemic (e.g., clinic closures, clinic staff pulled to help with COVID-19 testing, staff quarantine and illness, and organizational coordinator staff turnover at various clinics), the start date for implementation ranged from April 2020 to December 2020, for the nine clinics. Since the interventions were all evidence based, they were to be implemented and used for all patients coming for care.

For evaluation of the implementation process and outcomes, each patient was asked whether they wanted to be a participant in this study. Being a participant required selecting the “I agree” option on the ACASI-based consent form for those 18 years or older. By consenting, the participant was allowing the use of deidentified data from their sexual history, patient satisfaction survey, and nonidentifying demographics, laboratory results, and STI-related treatment data from their EHR from the date of consent through the end of the data collection period on August 31, 2021.

The voluntary option to participate in this study was explained by the project coordinator at each clinic when explaining the ACASI sexual history survey and the importance of completing it as part of the clinical care visit to each patient the first time. Flyers were also posted in the clinic to explain the study. Patients not agreeing to participate in this evaluative study were provided the same interventions as those who did consent to participate.

For each consented participant, an identification number was assigned by the research coordinator obtaining the consent. All identification numbers started with two letters representing the jurisdiction (DC, FL, or LA), followed by either 01, 02, or 03 identifying which clinic in the jurisdiction (assigned alphabetically), and then four more numbers. This identification number was used for pulling consented participant data from the ACASI files (completed sexual histories, recommended STI testing summaries, and patient satisfaction surveys), as well as from the EHR.

Each clinic was asked to create files of ACASI data (sexual history data and patient satisfaction data) and EHR data (including nonidentifying demographics and bacterial STI laboratory results), and an Excel spreadsheet of participant follow-up and treatment interventions done after a positive bacterial STI result. These three data files (ACASI, EHR, and Excel) were uploaded into a secure portal created specifically for this project. For evaluation of the LGBTQ+ indicators, each research coordinator manually entered the date of initial implementation for each of LGBTQ+ welcoming clinical space indicators into the data portal. If an LGBTQ+ welcoming clinical space indicator was already in place before starting this project, that was noted instead of the exact implementation date.

As a means of estimating the costs involved in STI-related care at each clinic, direct patient care and nondirect patient care time efforts were noted by each care team member over a 2-week period at the start of the intervention implementation and at 3–6 months after initiation of the interventions. Contact was defined as time (duration) spent directly with patients, including face-to-face encounters, telephone, text, and email contact, related to STI-specific issues. Nonclient contact was defined as STI-related activities done without direct patient interaction and included staff STI training, program record-keeping/charting, department of health (DOH) surveillance reporting, setting up patient referrals or appointments such as for a lumbar puncture related to syphilis, and ordering and stocking STI testing and treatment supplies.

The same was done for supplies needed for STI-related care paid for by the clinic (i.e., specimen collection kits provided without cost to clinics from the laboratory). One-time costs included start-up costs specifically for the supplies and equipment for the STI SPNS interventions but did not include the cost of setting up the ACASI-based surveys. The cost estimates did not include time spent on evaluation efforts for the project. They were only for clinical care related expenses pertaining to STIs. These costs were manually entered into the portal system by the research coordinators.

This supplement of AIDS Patient Care and STDs contains articles related to this evaluative study of implementation of the four training, clinical, and nonclinical interventions—the aggregate study results, individual intervention impact, jurisdictional findings, and results from different types of clinical demonstration sites.