Posts classified under: STDs and STIs

STI Screening as a Combined HIV Prevention Platform for MSM in Peru

Abstract: Periodic counseling, testing, and treatment for rectal sexually transmitted infections (STIs) provides a multi- dimensional platform to integrate behavioral and biological HIV prevention strategies for men who have sex with men (MSM) in Peru. Rectal STIs like gonorrhea and chlamydia are key risk factors for HIV acquisition among MSM, both as indirect behavioral markers of recent unprotected receptive anal intercourse (URAI), and as inflammatory factors that increase cellular risk for HIV co-transmission. However, there have been no prospective studies of interventions addressing the specific behavioral and biological risk factors associated with rectal STI transmission or the potential impact on HIV transmission risk of integrating rectal GC/CT screening with other prevention services. We will use nucleic acid testing to screen 750 behaviorally high-risk MSM for rectal gonorrheal and/or chlamydial (GC/CT) infection. GC/CT-positive subjects will receive single-dose antibiotic treatment and either single-session Personal Cognitive Counseling (PCC) (n=50) or standard post-test counseling (n=50). A GC/CT-negative control group (n=50) will also be enrolled to compare biological outcomes including changes in levels of inflammatory cytokines following rectal STI. Aim 1: To adapt a Personalized Cognitive Counseling (PCC) model for use with MSM in Peru. Aim 2: To adapt and pre-test the SJEI and behavioral assessment instruments for use with MSM in Peru. Aim 3: To pilot a combined HIV prevention intervention based on rectal STI counseling, testing, and treatment for MSM in Peru. Estimates of feasibility/acceptability of the intervention, GC/CT prevalence/re-infection rate and the effect on behavioral and biological mediators of HIV infection will be used to plan an R01 evaluation of rectal STI surveillance as HIV prevention for MSM in Peru.

Project Number: 5R01MH105272-03

Doxycycline Prophylaxis or Incentive Payments to Reduce Syphilis among HIV-infected Men Who Have Sex with Men

This pilot study will investigate the feasibility of conducting a large, randomized trial comparing a structural intervention to contingency management to reduce incident syphilis infections in an especially high risk group: HIV+ men who have sex with men (MSM) who have had syphilis twice or more since their HIV diagnosis. Subjects will be randomized to receive either QD doxycycline as syphilis prophylaxis or a financial incentive to remain STI free.

We will : 1) measure adherence to study visits in both arms; 2) measure adherence to the prophylaxis regimen; 3) measure any changes in risk behaviors among study participants and 4) to the extent possible in a small pilot study of short duration, compare effectiveness of doxycycline with that of a monetary incentive for remaining STI free.

Targeted Risk Group

 HIV+ men who have sex with men (MSM) who have had syphilis twice or more since their HIV diagnosis.

Intervention Model

Subjects will be randomized to receive either 1) Doxycycline, 100 mg. to be taken once daily or 2) an incentive for remaining STI free.

Local Significance 

Results of this study can be used to inform public health policy and programs to reduce risk of STI and HIV transmission among HIV+ “core transmitters,” and can also be easily extended to HIV negative MSM with repeated STIs. With the preliminary data from this study we hope to apply for further funding to support a larger, multisite definitive study incorporating one or both of the current interventions.

 

 

Comunidades Positivas “Positive Communities”

Also known as Prevention For Positives (P4P), this is a five-year, NIMH-funded study that tests two interventions  — one behavioral and one biomedical — to prevent HIV and STI (sexually transmitted infection) transmission among HIV- and/or STI-positive men who have sex with men in Lima, Peru.

This study evaluates two interventions carried-out simultaneously – one which is community-based and focuses on behavioral modification, and the other to improve access and service coverage for contacts of index cases for various sexually transmitted infections (STIs) – in order to prevent the transmission of HIV and STIs in Peru. Comunidades Positivas, the behavioral intervention, is designed to reduce the frequency of unprotected sex with non-primary partners. The biomedical intervention is designed to evaluate the effectiveness of enhanced partner therapy for incident STIs with the goal of reducing re-infection rates and therefore, incident STIs.

 

Penile Hygiene

This feasibility study investigates promotion of an existing social norm, post-coital penile cleansing, and its potential as an HIV prevention behavioral intervention.

We test participants’ ability to understand the study-specific counseling and consistently adhere to a genital hygiene regimen. One feature of this HIV prevention feasibility trial will be the ability to measure participants’ adherence to respective randomization arms by taking penile swabs before, during and at the end of the study.

If the approach proves efficacious, which would require a randomized controlled trial, it would provide an additional alternative for those men who are unwilling to undergo male circumcision and/or use condoms or reduce the number of sexual partners, but who wish to protect themselves from HIV.

Ai Shi Zi

Ai Shi Zi is a five-year NIMH-funded prevention and treatment study, the goal of which is to teach physicians how to enhance prevention and care for HIV and STIs. Because HIV and STIs are closely linked, prevention requires both state-of-the-art treatment and changes in sexual behavior. This study aims to teach physicians how to focus on both of these elements.

A total of 60 counties in China’s Anhui Province will be randomly assigned to one of two conditions: 1) primary and secondary training, in which county-level physicians are trained and, in turn, train township-level physicians; and 2) delayed-intervention control, in which physicians receive training only at the end of the 12-month assessment. Our primary endpoint is a hypothesized reduction in the one-year incidence of Chlamydia and gonorrhea among patients of trained county- and township-level physicians relative to delayed-intervention controls. Physicians and patients at the county- and township-levels will also be assessed using questionnaires at baseline and at 6 and 12 months following baseline.

Local significance (How has this project impacted the immediate population?):

This project provides training to county- and township-level physicians in Anhui Province, China and, hopefully, improved  care and treatment to their patients at risk for STIs, including HIV.

International significance (How has this project impacted the global community?):

This study may provide a useful model for training of physicians in a variety of developing country settings who care for patients at risk for STIs, including HIV.

Feasibility Study of a Community Level, Multi-Component, Intervention for Black MSM

To ascertain the feasibility and acceptability of an intervention among Black men who have sex with men (MSM), to prepare for a community-level randomized trial to test the efficacy of the intervention in reducing HIV incidence among Black MSM.

Approximately 2136 “first wave” participants (267 per site at eight sites) and approximately 400 referred partners (70 per site at six sites). There will be no limit on enrollment of participants referred by “index” participants already in the study (according to the referring scheme in the protocol). Index participants are defined later in the protocol, but can be generally described as those newly identified with HIV infection, those with previously diagnosed HIV infection who are not receiving HIV care, and certain HIV negative participants. Men enrolling for this study who have not been referred by an index participant will be called “first wave” participants. Enrollment of first wave participants will cease when 200 first wave participants eligible for longitudinal follow up have been enrolled. Enrollment of certain sub-categories of first wave participants will be limited according to criteria detailed in the protocol.

Treatment Regimen:

The intervention components provided to participants include: HIV risk-reduction counseling, testing and referral for care STI testing and referral for care Screening for substance use and mental health issues, and provision of counseling and referral for care (if indicated) Engagement with peer-health navigators to facilitate uptake of healthcare and other services Enumeration of up to 20 social and sexual network members by all participants and referral of up to 5 sexual partners by index participants for enrollment into the study

Primary Objectives:

To obtain information needed to design the full community-randomized trial, particularly in the areas of: recruitment of black MSM satisfaction of Black MSM with intervention components uptake of the intervention components by Black MSM, including: Proportion of enrolled participants who agree to HIV testing Proportion of participants who agree to STI testing Proportion of participants who utilize peer navigator referrals Proportion of HIV infected participants entering HIV care Increase in condom use in all participants from enrollment to week 52 Decrease in viral load among HIV infected participants from initiation of HAART to week 52 Decrease in STIs among all participants from enrollment to week 52

Secondary Objectives:

To collect samples, behavioral data and HIV test results to improve laboratory measures of HIV incidence based on samples derived from cross-sectional studies To estimate the HIV incidence rate and the effect of the intervention on the incidence rate through mathematical modeling To describe characteristics of sexual network members of black MSM who are newly diagnosed with HIV infection, or previously diagnosed but not in care To assess attitudes of black MSM toward other prevention interventions To describe social and sexual networks of Black MSM within cities to inform decisions about what constitutes a randomizable unit for a future trial of the intervention.

Study Sites:
• Atlanta: Emory University
• Boston: Fenway Community Health Center
• Los Angeles: University of California Los Angeles
• New York City: New York Blood Center/Harlem Hospital
• San Francisco: San Francisco Department of Public Health
• Washington DC: George Washington University

Interventions, Training Manuals, etc. :
[Download not found]

Hep-Safe Hollywood

Homeless, stimulant-using gay/bisexual men and transgender women are at high risk for hepatitis B virus (HBV), hepatitis C virus (HCV), and HIV infection due to high rates of injection drug use and high-risk sexual behaviors. Thus, use of stimulants threatens to intensify homeless persons’ risk of exposure to hepatitis B, C viruses and HIV; therefore, research focused on this group is critical. A contingency management (CM) intervention may be particularly well suited for this high-risk population. CM is an intervention that attempts to modify a targeted behavior by providing incentives for changing that behavior (in simple terms, positive reinforcement). CM interventions have been successfully implemented among stimulant-using gay and bisexual men to reduce drug use and concomitant sexual risk behaviors.

The Hep-Safe Hollywood study will implement a CM intervention to increase successful HAV/HBV vaccination completion programs among homeless, stimulant-using gay/bisexual men and transgender in Hollywood. This randomized, control trial will assign 500 homeless, stimulant-using gay and bisexual men to either an enhanced nurse case managed program, which includes specialized education and CM, or a standard program, which includes brief education and CM. This study is innovative in that it will allow us to look at the effect of an enhanced nurse case management and CM program versus a standard brief education and CM program. The study will evaluate the effectiveness of homeless, stimulant-using gay/bisexual men and transgender women on completion of the HAV/HBV vaccine and, secondarily, on reduction of risk for hepatitis and HIV. Additionally, the study will assess the relative cost of these programs in terms of completion of the vaccine series. The study combines best strategies to approach, engage and intervene with this hidden and high-risk population and to assess the feasibility and efficacy of interventions that may prove beneficial in preventing hepatitis A, B, C and HIV infections.

This study is a collaboration between UCLA School of Nursing and Friends Research Institute, with Dr. Adeline Nyamathi, as the principal investigator.

 

HIV/STD Risk Behaviors in Methamphetamine User Networks

SATH-CAP stands for the Sexual Acquisition and Transmission of HIV Cooperative Agreement Program. The overall goal of SATH-CAP is to better understand how patterns of sexual and drug use behaviors along with other social and environmental factors, such as other sexually transmitted diseases, places where people gather for sex and drug activities, and types of partnerships, influence the spread of HIV/AIDS from people currently at high risk for HIV/AIDS, like drug users and men who have sex with men (MSM), to those at a lower risk.

Specifically, the study seeks to answer these primary questions:

  • To what extent do HIV infections among drug-using populations spread to uninfected drug users and non-drug users through drug-related and/or sexual transmission behaviors?
  • What individual (behavioral, biological), network, and structural characteristics influence the speed, extent and path of the spread?

The SATH-CAP includes five research centers, a scientific and logistical coordinating center at RAND, and the funder, the National Institute on Drug Abuse (NIDA). The research centers are:

  • Research Triangle Institute (RTI)
  • University of California, Los Angeles (UCLA)
  • University of Illinois, Chicago (UIC)
  • Yale University
  • The Biomedical Center (BMC), St. Petersburg, Russia, Andrei Kozlov

Rectal Transmission of STIs/HIV among Women

While the prevalence and epidemiology of rectal sexually transmitted infections (STIs) are well characterized among men who have sex with men (MSM), little is known about rectal STIs in women. Evidence demonstrates that women also practice anal intercourse (AI) and are therefore at risk for these infections. The proposed study will investigate contextual factors as well as the prevalence and correlates of rectal STIs among women attending public sexually transmitted disease (STD) clinics in Los Angeles County (LAC) and determine if women who report substance use have differing risks for rectal STIs as compared to women who do not report substance use.

The specific aims of the project are to:
(1) identify contextual factors, which influence AI and the acquisition of rectal C. trachomatis and/or N. gonorrhoeae infection among women, comparing the particular context of substance use;
(2) measure the prevalence and correlates of rectal C. trachomatis and/or N. gonorrhoeae infection among women and determine whether this varies by substance use status.

Unprotected AI is recognized as one of the most efficient modes of HIV sexual transmission and is a commonly practiced behavior with opposite sex partners, with estimates of AI ranging from 7-40% in the United States. It is well established that HIV transmission probabilities are increased in the presence of STIs and there is evidence to suggest that among heterosexuals who report recent AI, about 60-80% report never using condoms suggesting they are likely to also be exposed to other STIs. Although it is clear that AI is a sexual practice with a high probability of transmission of HIV, data on the prevalence and incidence of rectal STIs among women reporting recent anal intercourse is limited. The proposed study will use both qualitative and quantitative methods to examine contextual and individual level factors associated with the acquisition of rectal STIs in women who report AI. Specifically, we will use the Theory of Gender and Power as a framework to examine AI and rectal STI-related exposures and risk factors among women attending the 12 public STD clinics in LAC (Aim 1). We will interview both women who are diagnosed with rectal C. trachomatis or N. gonorrhoeae infection and women who are not diagnosed with these infections, in order to identify key differences, particularly by substance use status. Concurrent to the qualitative assessment we will collect quantitative information available as part of the standard of care within the STD clinics. Currently, all clinics collect demographic and risk behavior information and conduct vaginal screening and rectal screening for C. trachomatis and N. gonorrhoeae among women who report AI. The laboratory testing results, along with medical record information will be used to provide estimates of the prevalence and correlates of rectal STIs and determine the extent to which this varies by substance use status (Aim 2).

The findings from this study will be one of the first to describe the prevalence and factors associated with rectal STIs among a relatively high risk group of women. At the end of the award period, these results will not only help inform overall rectal screening guidelines for women but will be used to develop a proposal designed to test a prevention intervention aimed at reducing the acquisition of rectal STIs/HIV among women.

HIV Counseling & Texting Program

The HIV Counseling and Texting (HCT) program utilizes social networks testing methodology, specifically designed to work with HIV infected and high-risk gay and bisexual men of color and transgender women. HIV infected or high-risk negative participants who either come to the Friends Community Center site for services or are contacted through street outreach and meet eligibility are invited to serve as recruiters. The engagement of new recruiters will be an active and ongoing part of the program. Potential recruiters attend a group orientation, which explains the social network methodology and informs potential recruiters that they will be requested to recruit individuals from their social, sexual or drug-using networks whom they believe to be at high-risk of HIV infection. Following the training period (brief identification, group orientation, individual interview), the recruiter begins to locate network associates to be referred to our testing site. Confirmatory HIV tests and STI testing (syphilis, Chlamydia, gonorrhea) are also available at the Friends Community Center site. Participants (both those who test HIV negative and positive) are then linked to appropriate medical, social, psychological, CRCS and other needed services. Network associates who wish to become recruiters are be assessed for eligibility and appropriateness.

This program is funded by the Los Angeles County, Department of Health Services, Office of AIDS Programs and Policy (OAPP).

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