Posts classified under: Comorbidities

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. :
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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.

Philani- Cape Town

There are four intersecting epidemics among pregnant women in South Africa: hazardous alcohol use (30%), HIV (27%), TB (60% of HIV+), img_5313and malnutrition (24% of infants). Unless the prevention programs for these epidemics are horizontally integrated, there will never be adequate resources to address these challenges and stigma will dramatically reduce program utilization. Furthermore, while clinics are the typical sites for treating each of these health problems, the NIAAA-funded Philani study is examining a home-visiting prevention program delivered by neighborhood Mentor Mothers (MM) as an alternative to clinic-based interventions to reduce the consequences of hazardous alcohol use, HIV, TB, and poor nutrition. The intervention encourages mothers to care for their own health, parent well, maintain their mental health, and, if the mother is living with HIV (HIV+ MAR), reduce HIV transmission and/or reduce alcohol use and abuse. The results begin to inform the optimal delivery strategy for the next generation of preventive interventions in order to be feasible and sustainable for broad dissemination immediately following an efficacy trial.

Targeted Risk Group:
Mothers at risk for hazardous alcohol use, HIV, TB, and malnutrition, as well as their infants

Published Journal Articles:

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Interventions, Training Manuals, etc: 

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Surveys/Scales Used: 
  1. Tolerance, Worried, Eye-Opener, Amnesia, Cut Down (TWEAK) - Survey
  2. Social Support - Survey
  3. Romantic Relationships - Survey
  4. Reproductive Health - Survey
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  6. Routines
  7. Relationships and Violence - Survey
  8. Household Characteristics and Composition - Survey
  9. AIDS Knowledge and Attitude for Pregnant Women - Survey
  10. Edinburgh Postnatal Depression Score (EPDS)
  11. Alcohol Use Disorders Identification Test (Audit C) - Scale
  12. Feeding Strategies to Prevent Transmission - Survey
  13. Medication Adherence - Survey
  14. Employment and Labor Experience Assessment - Survey
  15. CDC Sexual Behavior Questions (CSBQ)
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  17. Alcohol and Other Drug Abuse (AOD) - Scale
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  19. HIV Testing Assessment - Survey
  20. General Medical History Assessment
  21. General Health Questionnaire

Intervention model:
Mothers who are thriving in the community are chosen to act as role models, i.e. mentor mothers, for mothers at risk in the same community. This is based on the positive peer deviant model. Mentor mothers conduct home visits during the course of the study.

Research Methods:
Twenty four neighborhoods were randomly assigned to the intervention (12 neighborhoods), i.e. a mentor mother home visiting program, or control condition (12 neighborhoods). There are two levels of nesting in the study. Mothers and their infants are nested within neighborhoods, and repeated observations over time are nested within individuals. Longitudinal random effect regression models will be used to account for the nesting and examine the efficacy of the intervention at improving the health of infants and their mothers over time.

Local Significance:
The study is ongoing so it is too early to draw conclusions on the effectiveness of the intervention. Preliminary results are promising and suggest the mentor mother program may be an efficient mechanism to conduct healthcare-related home visits.

International Significance:
If found to be efficacious, the home-visiting model that relies on paraprofessionals, i.e. trained mentor mothers, offers a viable alternative to clinic-based healthcare and or care that requires professional healthcare providers that may not be practical in poorer countries outside the U.S.

Masihambisane – Pregnant Women: KZN

There are four intersecting epidemics among pregnant women in South Africa: hazardous alcohol use (30%), HIV (27%), TB (60% of HIV+), and malnutrition (24% of infants). Unless the prevention programs for these epidemics are horizontally integrated, there will never be adequate resources to address these challenges and stigma will dramatically reduce program utilization. Since clinics are the typical sites for treating each of these health problems, the NIMH-funded Masihambisane study is examining a clinic-based prevention program delivered by neighborhood Mentor Mothers (MM) to reduce the consequences of hazardous alcohol use, HIV, TB, and poor nutrition. The intervention encourages mothers to care for their own health, parent well, maintain their mental health, and, if the mother is living with HIV (HIV+ MAR), reduce HIV transmission and/or reduce alcohol use and abuse. The results begin to inform the optimal delivery strategy for next generation of preventive interventions in order to be feasible and sustainable for broad dissemination immediately following an efficacy trial.

Targeted Risk Group: 

Mothers at risk for hazardous alcohol use, HIV, TB, and malnutrition, as well as their infants

Published Journal Articles :

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Interventions, Training Manuals, etc. :  

Surveys and Scales Used: 

Intervention model:  
In the intervention arm, participants will receive the Department of Health-delivered Prevention of Mother to Child Transmission (PMTCT) program plus the Project Masihambisane mentor mothers support program, delivered by HIV-positive mentor mothers. HIV-positive mentor mothers are women who are thriving in the community and who have been through the PMTCT program. They have been recruited and trained to deliver the intervention to pregnant mothers living with HIV.

Research Methods: 

Eight clinics were randomly assigned to the intervention (4 clinics) or control condition (4 clinics). There are two levels of nesting in the study. Mothers and their infants are nested within clinics, and repeated observations over time are nested within individuals. Longitudinal random effect regression models will be used to account for the nesting and examine the efficacy of the intervention at improving the health of infants and their mothers over time.

Local Significance: 

The study is ongoing so it is too early to draw conclusions on the effectiveness of the intervention and the local significance.

International Significance: 

The study is ongoing so it is too early to draw conclusions on the effectiveness of the intervention and the local significance.

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