Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women.

BACKGROUND: Safe and effective long-acting injectable agents for preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection are needed to increase the options for preventing HIV infection. METHODS: We conducted a randomized, double-blind, double-dummy, noninferiority trial to compare long-acting injectable cabotegravir (CAB-LA, an integrase strand-transfer inhibitor [INSTI]) at a dose of 600 mg, given intramuscularly every 8 weeks, with daily oral tenofovir disoproxil fumarate-emtricitabine (TDF-FTC) for the prevention of HIV infection in at-risk cisgender men who have sex with men (MSM) and in at-risk transgender women who have sex with men. Participants were randomly assigned (1:1) to receive one of the two regimens and were followed for 153 weeks. HIV testing and safety evaluations were performed. The primary end point was incident HIV infection. RESULTS: The intention-to-treat population included 4566 participants who underwent randomization; 570 (12.5%) identified as transgender women, and the median age was 26 years (interquartile range, 22 to 32). The trial was stopped early for efficacy on review of the results of the first preplanned interim end-point analysis. Among 1698 participants from the United States, 845 (49.8%) identified as Black. Incident HIV infection occurred in 52 participants: 13 in the cabotegravir group (incidence, 0.41 per 100 person-years) and 39 in the TDF-FTC group (incidence, 1.22 per 100 person-years) (hazard ratio, 0.34; 95% confidence interval, 0.18 to 0.62). The effect was consistent across prespecified subgroups. Injection-site reactions were reported in 81.4% of the participants in the cabotegravir group and in 31.3% of those in the TDF-FTC group. In the participants in whom HIV infection was diagnosed after exposure to CAB-LA, INSTI resistance and delays in the detection of HIV infection were noted. No safety concerns were identified. CONCLUSIONS: CAB-LA was superior to daily oral TDF-FTC in preventing HIV infection among MSM and transgender women. Strategies are needed to prevent INSTI resistance in cases of CAB-LA PrEP failure. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 083 ClinicalTrials.gov number, NCT02720094.).

Epidemiology of Mpox Cases, and Tecovirimat and JYNNEOS Utilization, Alameda County, California, June-October 2022.

CONTEXT: The 2022 United States mpox outbreak disproportionately affected racial and ethnic minority gay, bisexual, and other men who have sex with men. PROGRAM: We utilized surveillance data and vaccination registries to determine whether populations most impacted by mpox in Alameda County received JYNNEOS vaccines and tecovirimat (TPOXX) during June 1-October 31, 2022. IMPLEMENTATION: Alameda County Public Health Department responded to the mpox epidemic through partnerships with local health care providers who serve communities disproportionately affected by mpox. EVALUATION: During June 1-October 31, 2022, a total of 242 mpox cases were identified in Alameda County. Mpox incidence rates per 100 000 were highest among Black/African American (35.7; 95% confidence interval [CI], 26.8-46.5) and Hispanic/Latinx (25.1; CI, 20.1-30.9) residents, compared to Asian (3.8; CI, 2.3-5.9) and White (10.5; CI, 7.7-13.9) residents. Most confirmed cases were identified as gay, lesbian, or same-gender-loving (134, 67.3%) and bisexual (31, 15.6%); 226 (93.8%) cases were male. Sixty-nine (28.5%) mpox patients received TPOXX. There were no statistically significant differences in demographic and clinical characteristics of mpox cases when compared by TPOXX receipt status. JYNNEOS vaccine was received by 8277 Alameda County residents. The largest proportion of vaccinees were White residents (40.2%). Administration rates per 100 000 men who have sex with men were lowest among Asian and Hispanic/Latinx individuals, at 8779 (CI, 8283-9296) and 14 953 (CI, 14 156-15 784), respectively. Black/African American and Hispanic/Latinx males had the lowest vaccination-to-case ratios at 16.7 and 14.8, respectively. DISCUSSION: Mpox disproportionately affected Black/African American and Hispanic/Latinx men who have sex with men in Alameda County. Strong partnerships with local health care providers ensured that persons with mpox received TPOXX treatment when indicated. However, higher JYNNEOS vaccine uptake in Black and Latinx communities needs improvement through ongoing and meaningful engagement with Black/African American and Hispanic/Latinx gay, bisexual, and transgender communities.

Acceptability of a Dapivirine/Placebo Gel Administered Rectally to HIV-1 Seronegative Adults (MTN-026).

This study describes the acceptability of a rectal microbicide gel formulation using dapivirine (DPV) among men and women from two countries (United States and Thailand) participating in the Microbicide Trials Network-026 trial. We evaluated participants' acceptability of a rectal DPV/placebo gel as part of a Phase I trial (N = 26; 18 male, 8 female). Participants reported favorable acceptability of the study gel, with most participants reporting that they liked the gel the same (n = 14; 53.8%) or more (n = 11; 42.4%) than when they started the trial. Over half of participants noted that they would prefer the gel over condoms (n = 13; 50%) or that they liked condoms and the gel equally (n = 8; 30.8%). Side effects across products included leakage (n = 8; 30.8%), diarrhea (n = 4; 15.4%), or soiling (n = 1; 3.8%). The high acceptability of a rectal gel underscores its promise as a short-acting biomedical prevention, warranting future research for HIV prevention.Trial Registration: NCT03239483.

RESUMEN: Este estudio describe la aceptabilidad de un microbicida rectal (RM) con dapivirina (DPV) formulado como un gel por hombres y mujeres de dos países (Estados Unidos y Tailandia) que participaron como parte del Microbicide Trials Network (MTN)-026. Evaluamos la aceptabilidad de un gel rectal de DPV y un placebo como parte de un estudio de Fase I (N = 26; 18 hombres, 8 mujeres). Los participants informaron una aceptabilidad favorable sobre el gel del estudio; la mayoría de los participantes informaron que les gustó el gel igual (n = 14; 53.8%) o más (n = 11; 42.4%) que cuando comenzaron el estudio. Más de la mitad de los participantes señalaron que preferirían el gel sobre los condones (n = 13; 50%) o que les gustaban los condones y el gel por igual (n = 8; 30,8%). Los efectos de los productos incluyeron fugas (n = 8; 30,8%), diarrea (n = 4; 15,4%) o ensuciamiento (n = 1; 3,8%). La alta aceptabilidad de un gel rectal enfatiza su promesa para la prevención biomédica de acción corta y justifica futuras investigaciones para la prevención del VIH.

HIV and syphilis prevalence among transgender women and men who have sex with men, Silom Community Clinic, Bangkok, Thailand, 2017-2019.

We assessed HIV and syphilis infection among MSM and TGW attending Silom Community Clinic from 2017 to 2019. Walk-in and referral clients completed a registration application including a question on gender identity. We compared the prevalence of HIV, syphilis, and HIV and syphilis coinfection among TGW and MSM. In a total of 1050 clients, 276 (26.3%) were TGW and 774 (74.7%) were MSM. Among TGW clients, HIV prevalence was 29.8%, syphilis prevalence was 38.4%, and coinfection prevalence was 18.5%. Comparing prevalence among TGW to MSM, the adjusted prevalence ratio (aPR) for HIV was 1.8 (95% CI:1.4-2.3), for syphilis was 1.2 (95% CI:1.0-1.4), and for HIV and syphilis coinfection was 2.1 (95% CI:1.4-2.9). The prevalence of syphilis was higher than HIV among TGW, with a PR of 1.3 (95% CI:1.1-1.6), and among MSM, with a PR of 1.4 (95% CI:1.2-1.7). TGW age 15-21 years had an HIV prevalence of 16.9% and syphilis prevalence of 30.8%. After adjusting for age, referral, and sexual behaviors, TGW remain significantly associated with HIV and syphilis prevalence. There is a substantial burden of HIV and HIV/syphilis co-infection among TGW. HIV/STI prevention are needed for TGW, including linkage to HIV care.

Young Men Who Have Sex with Men at High Risk for HIV, Bangkok MSM Cohort Study, Thailand 2006-2014.

High HIV incidence has been reported in young men who have sex with men (YMSM) in North America and Western Europe, but there are limited data from Southeast Asia suggesting MSM may be the driver of the HIV epidemic in this region. We described HIV incidence and risk factors among 494 YMSM enrolled in a cohort study in Bangkok, Thailand. The HIV incidence was 7.4 per 100 person-years. In multivariable analysis, reporting use of an erectile dysfunction drug in combination with club drugs, having receptive or both insertive and receptive anal intercourse with men, having hepatitis A infection, having rectal Chlamydia trachomatis, having hepatitis B infection prior to HIV seroconversion, and reporting not always using condoms with male steady partners were significantly associated with HIV incidence in YMSM. Reduction in new HIV infections in YMSM are critical to reach targets set by Thailand and the region.

Reduction in Human Papillomavirus Vaccine Type Prevalence Among Young Women Screened for Cervical Cancer in an Integrated US Healthcare Delivery System in 2007 and 2012-2013.

BACKGROUND: In the United States, human papillomavirus (HPV) vaccine is recommended for 11- or 12-year-olds, and for young adults not previously vaccinated. Early vaccine impact can be measured by reductions in vaccine-type (VT) HPV prevalence. METHODS: Consecutive residual cervical specimens were retained from women aged 20-29 years at Kaiser Permanente Northwest in 2007, 2012, and 2013. HPV genotypes were determined using L1 consensus polymerase chain reaction with type-specific hybridization to detect 37 types, including VT HPV (HPV type 6, 11, 16, and 18). We compared HPV prevalence in 2007 and 2012-2013, and we evaluated predictors of VT HPV and any-HPV prevalence in 2012-2013. RESULTS: In 2012-2013, 31.9% of 4181 women had initiated HPV vaccination. VT HPV prevalence decreased from 10.6% in 2007 to 6.2% in 2012-2013 (P < .001). In 2012-2013, VT HPV prevalence was significantly lower among those who initiated vaccination <19 years (adjusted prevalence ratio, 0.1; 95% confidence interval, .1-.3) than among those who were not vaccinated, and higher among those who had chlamydia, human immunodeficiency virus, or pregnancy testing in the past year than among those who did not (adjusted prevalence ratio, 1.4; 95% confidence interval, 1.1-1.8). CONCLUSIONS: Reduction in VT HPV was found in young women in an integrated healthcare delivery system within 6 years of vaccine introduction, indicating early HPV vaccine impact.

Human Papillomavirus and Genital Warts: A Review of the Evidence for the 2015 Centers for Disease Control and Prevention Sexually Transmitted Diseases Treatment Guidelines.

To provide updates for the 2015 Centers for Disease Control and Prevention sexually transmitted diseases treatment guidelines on human papillomavirus (HPV) and anogenital warts (AGWs), a review of the literature was conducted in key topic areas: (1) epidemiology and burden of disease; (2) transmission and natural history; (3) diagnosis and management of AGWs; (4) occupational exposure of healthcare workers; (5) anal cancer screening among men who have sex with men (MSM); and (6) HPV vaccine recommendations. Most sexually active persons will have detectable HPV at least once in their lifetime; 14 million persons are infected annually, and 79 million persons have prevalent infection. HPV is transmitted frequently between partners; more frequent transmission has been reported from females to males than from males to females. A new formulation of imiquimod (3.75% cream) is recommended for AGW treatment. Appropriate infection control, including performing laser or electrocautery in ventilated rooms using standard precautions, is recommended to prevent possible transmission to healthcare workers who treat anogenital warts, oral warts, and anogenital intraepithelial neoplasias (eg, cervical intraepithelial neoplasia). Data are insufficient to recommend routine anal cancer screening with anal cytology in persons living with human immunodeficiency virus (HIV)/AIDS or HIV-negative MSM. An annual digital anorectal examination may be useful for early detection of anal cancer in these populations. HPV vaccine is recommended routinely for 11- or 12-year-olds, as well as for young men through age 21 years and young women through age 26 years who have not previously been vaccinated. HPV vaccine is also recommended for MSM, people living with HIV/AIDS, and immunocompromised persons through age 26 years.

Human papillomavirus vaccination: recommendations of the Advisory Committee on Immunization Practices (ACIP).

This report summarizes the epidemiology of human papillomavirus (HPV) and associated diseases, describes the licensed HPV vaccines, provides updated data from clinical trials and postlicensure safety studies, and compiles recommendations from CDC's Advisory Committee on Immunization Practices (ACIP) for use of HPV vaccines. Persistent infection with oncogenic HPV types can cause cervical cancer in women as well as other anogenital and oropharyngeal cancers in women and men. HPV also causes genital warts. Two HPV vaccines are licensed in the United States. Both are composed of type-specific HPV L1 protein, the major capsid protein of HPV. Expression of the L1 protein using recombinant DNA technology produces noninfectious virus-like particles (VLPs). Quadrivalent HPV vaccine (HPV4) contains four HPV type-specific VLPs prepared from the L1 proteins of HPV 6, 11, 16, and 18. Bivalent HPV vaccine (HPV2) contains two HPV type-specific VLPs prepared from the L1 proteins of HPV 16 and 18. Both vaccines are administered in a 3-dose series. ACIP recommends routine vaccination with HPV4 or HPV2 for females aged 11 or 12 years and with HPV4 for males aged 11 or 12 years. Vaccination also is recommended for females aged 13 through 26 years and for males aged 13 through 21 years who were not vaccinated previously. Males aged 22 through 26 years may be vaccinated. ACIP recommends vaccination of men who have sex with men and immunocompromised persons (including those with HIV infection) through age 26 years if not previously vaccinated. As a compendium of all current recommendations for use of HPV vaccines, information in this report is intended for use by clinicians, vaccination providers, public health officials, and immunization program personnel as a resource. ACIP recommendations are reviewed periodically and are revised as indicated when new information and data become available.

Prevalence of cervical and oral human papillomavirus infections among US women.

Data from the National Health and Nutrition Examination Survey, 2009-2010, indicated that the prevalence of human papillomavirus (HPV) infection among women was 42.7% in the cervix and 3.8% in the oral cavity. The prevalence of oral HPV infection was 5-fold higher among women with than among those without cervical HPV infection (7.0% vs 1.4%; prevalence ratio, 4.9 [95% confidence interval, 2.7-8.7]). Among the 3% of women with HPV detected at both sites, complete type concordance was detected in 6.6%, and partial agreement was detected in 37.7%. These data suggest that HPV infections at these 2 sites are not independent, although type-specific concordance is low.

Prevaccine era human papillomavirus types 6, 11, 16 and 18 seropositivity in the U.S.A., National Health and Nutrition Examination Surveys, 2003-2006.

BACKGROUND: A vaccine is available to prevent human papillomavirus (HPV) 6, 11, 16 and 18; in the prevaccine era, seropositivity to vaccine types is a measure of natural exposure. METHODS: We describe HPV seropositivity in the USA among 14-59-year-olds using the 2003-2006 National Health and Nutrition Examination Surveys. RESULTS: Seropositivity to HPV 6, 11, 16 and 18 was 17.5%, 6.8%, 15.1% and 5.9%, respectively, among women, and 7.0%, 2.4%, 5.2% and 1.5%, respectively, among men. Overall in both sexes, seropositivity was 22.5% for any vaccine type (31.8% in women and 12.9% in men), but substantially lower for three or more types (1.7% overall, 2.8% in women and 0.6% in men). CONCLUSIONS: Almost a quarter of the participants were seropositive to any HPV vaccine type but few were seropositive to at least three vaccine HPV types in the prevaccine era. Further study is needed to assess if seropositivity would be useful as a biological marker of vaccination.

The estimated lifetime probability of acquiring human papillomavirus in the United States.

BACKGROUND: Estimates of the lifetime probability of acquiring human papillomavirus (HPV) can help to quantify HPV incidence, illustrate how common HPV infection is, and highlight the importance of HPV vaccination. METHODS: We developed a simple model, based primarily on the distribution of lifetime numbers of sex partners across the population and the per-partnership probability of acquiring HPV, to estimate the lifetime probability of acquiring HPV in the United States in the time frame before HPV vaccine availability. RESULTS: We estimated the average lifetime probability of acquiring HPV among those with at least 1 opposite sex partner to be 84.6% (range, 53.6%-95.0%) for women and 91.3% (range, 69.5%-97.7%) for men. Under base case assumptions, more than 80% of women and men acquire HPV by age 45 years. CONCLUSIONS: Our results are consistent with estimates in the existing literature suggesting a high lifetime probability of HPV acquisition and are supported by cohort studies showing high cumulative HPV incidence over a relatively short period, such as 3 to 5 years.

Evaluation of a surveillance case definition for anogenital warts, Kaiser Permanente northwest.

BACKGROUND: Most studies of anogenital wart (AGW) epidemiology have used large clinical or administrative databases and unconfirmed case definitions based on combinations of diagnosis and procedure codes. METHODS: We developed and validated an AGW case definition using a combination of diagnosis codes and other information available in the electronic medical record (provider type, laboratory testing). We calculated the positive predictive value (PPV) of this case definition compared with manual medical record review in a random sample of 250 cases. Using this case definition, we calculated the annual age- and sex-stratified prevalence of AGW among individuals 11 through 30 years of age from 2000 through 2005. RESULTS: We identified 2730 individuals who met the case definition. The PPV of the case definition was 82%, and the average annual prevalence was 4.16 per 1000. Prevalence of AGW was higher in females compared with males in every age group, with the exception of the 27- to 30-year-olds. Among females, prevalence peaked in the 19- to 22-year-olds, and among males, the peak was observed in 23- to 26-year-olds. CONCLUSIONS: The case definition developed in this study is the first to be validated with medical record review and has a good PPV for the detection of AGW. The prevalence rates observed in this study were higher than other published rates, but the age- and sex-specific patterns observed were consistent with previous reports.

The estimated impact of human papillomavirus vaccine coverage on the lifetime cervical cancer burden among girls currently aged 12 years and younger in the United States.

Using a previously published dynamic model, we illustrate the potential benefits of human papillomavirus vaccination among girls currently 12 years or younger in the United States. Increasing vaccine coverage of young girls to 80% would avert 53,300 lifetime cervical cancer cases versus 30% coverage and 28,800 cases versus 50% coverage.

Would young women attending sexually transmitted disease clinics benefit from human papillomavirus vaccination? An assessment of human papillomavirus DNA and seropositivity from human papillomavirus sentinel surveillance, 2003-2005.

BACKGROUND: There are limited data on the proportion who have been exposed to vaccine-type human papillomavirus (HPV) among women attending sexually transmitted disease (STD) clinics; this information could inform the potential benefits of HPV vaccination for women attending this venue. METHODS: Human papillomavirus surveillance was conducted in STD clinics in Baltimore, MD; Boston, MA; Denver, CO; Los Angeles, CA; and Seattle, WA, among women receiving cervical cancer screening from January 2003 to December 2005. The women had specimens collected for cervical cytology HPV testing by L1 consensus polymerase chain reaction testing and serologic assessment for HPV 6, 11, 16, and 18 using the competitive Luminex immunoassay. Results from 880 women with adequate specimens were included. Women were HPV naïve if they were both HPV DNA negative and seronegative for a specific HPV type. RESULTS: One hundred seventy women (19.3%) had HPV 16, 18, 6, or 11 DNA, and 418 (47.5%) were HPV 16, 18, 6, or 11 seropositive. Four hundred ten (46.6%) women were naïve to all 4 types, 570 (64.8%) were naïve to both HPV 16 and 18, and 545 (61.9%) were naïve to both HPV 6 and 11. Almost all (99.3%) women were naïve to at least 1 vaccine HPV type. CONCLUSIONS: Almost half of young women age eligible for HPV vaccine and attending STD clinics were naïve to all 4 HPV types, and more than half were naïve to both HPV 16 and 18. This assessment suggests that most young women attending this venue might benefit from HPV vaccination.

CDC grand rounds: Reducing the burden of HPV-associated cancer and disease.

Human papillomavirus (HPV) infection is the most common sexually transmitted infection in men and women in the United States. Most sexually active persons will acquire HPV in their lifetime. Recent data indicate that approximately 79 million persons are currently infected with HPV, and 14 million persons are newly infected each year in the United States.

Preparing for human papillomavirus vaccine introduction in Kenya: implications from focus-group and interview discussions with caregivers and opinion leaders in Western Kenya.

BACKGROUND: Cervical cancer claims the lives of 275,000 women each year; most of these deaths occur in low-or middle-income countries. In Kenya, cervical cancer is the leading cause of cancer-related mortality among women of reproductive age. Kenya's Ministry of Public Health and Sanitation has developed a comprehensive strategy to prevent cervical cancer, which includes plans for vaccinating preteen girls against human papillomavirus (HPV) by 2015. To identify HPV vaccine communication and mobilization needs, this research sought to understand HPV vaccine-related perceptions and concerns of male and female caregivers and community leaders in four rural communities of western Kenya. METHODS: We conducted five focus groups with caregivers (n = 56) and 12 key-informant interviews with opinion leaders to explore cervical cancer-related knowledge, attitudes and beliefs, as well as acceptability of HPV vaccination for 9-12 year-old girls. Four researchers independently reviewed the data and developed codes based on questions in interview guides and topics that emerged organically, before comparing and reconciling results through a group consensus process. RESULTS: Cervical cancer was not commonly recognized, though it was understood generally in terms of its symptoms. By association with cancer and genital/reproductive organs, cervical cancer was feared and stigmatized. Overall acceptability of a vaccine that prevents cervical cancer was high, so long as it was endorsed by trusted agencies and communities were sensitized first. Some concerns emerged related to vaccine safety (e.g., impact on fertility), program intent, and health equity. CONCLUSION: For successful vaccine introduction in Kenya, there is a need for communication and mobilization efforts to raise cervical cancer awareness; prompt demand for vaccination; address health equity concerns and stigma; and minimize potential resistance. Visible endorsement by government leaders and community influencers can provide reassurance of the vaccine's safety, efficacy and benefits for girls and communities. Involvement of community leadership, parents and champions may also be critical for combatting stigma and making cervical cancer relevant to Kenyan communities. These findings underscore the need for adequate planning and resources for information, education and communication prior to vaccine introduction. Specific recommendations for communication and social-marketing strategies are made.

Reduction in human papillomavirus (HPV) prevalence among young women following HPV vaccine introduction in the United States, National Health and Nutrition Examination Surveys, 2003-2010.

BACKGROUND: Human papillomavirus (HPV) vaccination was introduced into the routine immunization schedule in the United States in late 2006 for females aged 11 or 12 years, with catch-up vaccination recommended for those aged 13-26 years. In 2010, 3-dose vaccine coverage was only 32% among 13-17 year-olds. Reduction in the prevalence of HPV types targeted by the quadrivalent vaccine (HPV-6, -11, -16, and -18) will be one of the first measures of vaccine impact. METHODS: We analyzed HPV prevalence data from the vaccine era (2007-2010) and the prevaccine era (2003-2006) that were collected during National Health and Nutrition Examination Surveys. HPV prevalence was determined by the Linear Array HPV Assay in cervicovaginal swab samples from females aged 14-59 years; 4150 provided samples in 2003-2006, and 4253 provided samples in 2007-2010. RESULTS: Among females aged 14-19 years, the vaccine-type HPV prevalence (HPV-6, -11, -16, or -18) decreased from 11.5% (95% confidence interval [CI], 9.2-14.4) in 2003-2006 to 5.1% (95% CI, 3.8-6.6) in 2007-2010, a decline of 56% (95% CI, 38-69). Among other age groups, the prevalence did not differ significantly between the 2 time periods (P > .05). The vaccine effectiveness of at least 1 dose was 82% (95% CI, 53-93). CONCLUSIONS: Within 4 years of vaccine introduction, the vaccine-type HPV prevalence decreased among females aged 14-19 years despite low vaccine uptake. The estimated vaccine effectiveness was high.

Cyclic changes in HIV shedding from the female genital tract during the menstrual cycle.

Factors increasing genital human immunodeficiency virus (HIV) shedding may increase female-to-male HIV transmission risk. We examined HIV shedding in 67 women with HIV type 1 and herpes simplex virus type 2 coinfection, during 2 menstrual cycles. Shedding occurred in 60%, 48%, and 54% of samples during the follicular, periovulatory, and luteal phases, respectively (P = .01). Shedding declined after menses until ovulation, with a slope -0.054 log10 copies/swab/day (P < .001), corresponding to a change of approximately 0.74 log10 copies between peak and nadir levels. Shedding increased during the luteal phase only among women with CD4 counts of <350 cells/µL. In reproductive-aged women, shedding frequency and magnitude are greatest immediately following menses and lowest at ovulation.

Perceived Feasibility and Acceptability of HIV Prevention Research With Daily Oral PrEP Among Young Transgender Women (YTGW) Who Sell or Trade Sex in Bangkok and Pattaya, Thailand.

Young transgender women (YTGW) who sell or trade sex have among the highest HIV incidence rates in Thailand. Using qualitative methods, we assessed perceived acceptability, feasibility, and optimal design of a combination HIV prevention intervention including PrEP for YTGW. Key informant interviews were conducted during July 2016-July 2018 with 21 YTGW, aged 18-26 years, who sold sex and resided in Bangkok or Pattaya, Thailand. Grounded theory and content analysis were used for data analysis. Most YTGW interviewed reported high interest in HIV prevention research and believed participation in it supported sexual health. However, participants perceived HIV studies as complicated and time-consuming. Regarding PrEP, participants suggested more PrEP options beyond daily oral PrEP and expressed concerns related to perceived side effects of PrEP, including interaction with gender-affirming hormone therapy. Improving PrEP knowledge, being able to self-assess HIV risk, and reducing HIV/PrEP stigma could increase interest in research and PrEP uptake among YTGW.

Data quality assessment of the Enhanced Gonococcal Antimicrobial Surveillance Programme (EGASP), Thailand, 2015-2021.

BACKGROUND: Quality assessments of gonococcal surveillance data are critical to improve data validity and to enhance the value of surveillance findings. Detecting data errors by systematic audits identifies areas for quality improvement. We designed and implemented an internal audit process to evaluate the accuracy and completeness of surveillance data for the Thailand Enhanced Gonococcal Antimicrobial Surveillance Programme (EGASP). METHODS: We conducted a data quality audit of source records by comparison with the data stored in the EGASP database for five audit cycles from 2015-2021. Ten percent of culture-confirmed cases of Neisseria gonorrhoeae were randomly sampled along with any cases identified with elevated antimicrobial susceptibility testing results and cases with repeat infections. Incorrect and incomplete data were investigated, and corrective action and preventive actions (CAPA) were implemented. Accuracy was defined as the percentage of identical data in both the source records and the database. Completeness was defined as the percentage of non-missing data from either the source document or the database. Statistical analyses were performed using the t-test and the Fisher's exact test. RESULTS: We sampled and reviewed 70, 162, 85, 68, and 46 EGASP records during the five audit cycles. Overall accuracy and completeness in the five audit cycles ranged from 93.6% to 99.4% and 95.0% to 99.9%, respectively. Overall, completeness was significantly higher than accuracy (p = 0.017). For each laboratory and clinical data element, concordance was >85% in all audit cycles except for two laboratory data elements in two audit cycles. These elements significantly improved following identification and CAPA implementation. DISCUSSION: We found a high level of data accuracy and completeness in the five audit cycles. The implementation of the audit process identified areas for improvement. Systematic quality assessments of laboratory and clinical data ensure high quality EGASP surveillance data to monitor for antimicrobial resistant Neisseria gonorrhoeae in Thailand.