An international randomized clinical trial (RCT) on pre-exposure prophylaxis (PrEP) as an human immunodeficiency virus (HIV)-prevention intervention found that taken on a daily basis, PrEP was safe and effective among men who have sex with men (MSM) and male-to-female transgender women. Within the context of the HIV epidemic in the United States (US), MSM and transgender women are the most appropriate groups to target for PrEP implementation at the population level; however, their perspectives on evidenced-based biomedical research and the results of this large trial remain virtually unknown. In this study, we examined the acceptability of individual daily use of PrEP and assessed potential barriers to community uptake.
We conducted semi-structured interviews with an ethnoracially diverse sample of thirty HIV-negative and unknown status MSM (n = 24) and transgender women (n = 6) in three California metropolitan areas. Given the burden of disease among ethnoracial minorities in the US, we purposefully oversampled for these groups. Thematic coding and analysis of data was conducted utilizing an approach rooted in grounded theory.
While participants expressed general interest in PrEP availability, results demonstrate: a lack of community awareness and confusion about PrEP; reservations about PrEP utilization, even when informed of efficacious RCT results; and concerns regarding equity and the manner in which a PrEP intervention could be packaged and marketed in their communities.
In order to effectively reduce HIV health disparities at the population level, PrEP implementation must take into account the uptake concerns of those groups who would actually access and use this biomedical intervention as a prevention strategy. Recommendations addressing these concerns are provided.
Men who have sex with men (MSM); Male-to-female (MTF) transgender women; HIV/AIDS; Pre-exposure prophylaxis (PrEP); Qualitative research; Health disparities
Zimbabwe’s HIV epidemic is amongst the worst in the world, and disproportionately effects poorer rural areas. Access to almost all health services in Zimbabwe includes some form of cost to the client. In recent years, the socio-economic and employment status of many Zimbabweans has suffered a serious decline, creating additional barriers to HIV treatment and care. We aimed to assess the impact of i) socio-economic status (SES) and ii) employment status on the utilization of health services in rural Zimbabwe. Data were collected from a random probability sample household survey conducted in the Mutoko district of north-western Zimbabwe in 2005. We selected variables that described the economic status of the respondent, including: being paid to work, employment status, and SES by assets. Respondents were also asked about where they most often utilized healthcare when they or their family was sick or hurt. Of 2,874 respondents, all forms of healthcare tended to be utilized by those of high or medium-high SES (65%), including private (65%), church-based (61%), traditional (67%), and other providers (66%) (P=0.009). Most respondents of low SES utilized government providers (74%) (P=0.009). Seventy-one percent of respondents utilizing health services were employed. Government (71%), private (72%), church (71%), community-based (78%) and other (64%) health services tended to be utilized by employed respondents (P=0.000). Only traditional health services were equally utilized by unemployed respondents (50%) (P=0.000). A wide range of health providers are utilized in rural Zimbabwe. Utilization is strongly associated with SES and employment status, particularly for services with user fees, which may act as a barrier to HIV treatment and care access. Efforts to improve access in low-SES, high HIV-prevalence settings may benefit from the subsidization of the health care payment system, efforts to improve SES levels, political reform, and the involvement of traditional providers.
Africa; socio-economic status; HIV/AIDS; access
We estimated HIV-1 incidence and characterized risk factors associated with recent infection among participants of a mobile HIV voluntary counseling and testing (VCT) pilot program in two communities in Zimbabwe (N = 1096). HIV-1 infection was diagnosed using a parallel rapid testing algorithm. Recent HIV-1 infections were characterized using the BED immunoglobulin G capture enzyme immunoassay (BED-CEIA). HIV prevalence was 28.9% overall and nearly twice as high in women compared to men (39.5% vs. 21.4%, p < 0.001). HIV-1 incidence was 1.91% and was comparable between men and women (1.99% vs.1.88%; p = 0.626). Although not significant, the proportion of recent infections among all infections was highest among persons ages 25 to 34 years old (10.5%) for both men (11.9%) and women (9.2%). Persons recently infected compared to those with long-term infections were more likely to report STD symptoms (33% vs. 13%; OR = 3.2; p = 0.075) and prior STD treatment (13% vs. 6%; OR = 3.4; p = 0.187) in the previous 6 months. There were no associations found between recent versus long-term HIV infection status and perceived risk or expectation of negative test results. Recent HIV-1 infection detection among mobile VCT participants is a valuable measure for tracking the spread of the epidemic among persons who might otherwise not have access to HIV testing due to practical and logistical barriers. Mobile VCT presents opportunities to expand HIV testing services and evaluate at-risk populations within community settings. Given the challenges of longitudinal cohort studies, recent infection may be a practical endpoint for community-based prevention intervention trials employing mobile testing.
Unprotected sexual intercourse remains a primary mode of HIV transmission in the United States. We found that receipt of services to reduce HIV transmission-risk behaviors was low among 3787 HIV-infected individuals and that men who have sex with men were especially unlikely to receive these services even though they were more likely to report unprotected sexual intercourse with seronegative and unknown serostatus casual partners. Greater efforts should be made to ensure that prevention counseling is delivered to all HIV-infected persons, especially men who have sex with men.
Despite high rates of patient satisfaction with emergency department (ED) HIV testing, acceptance varies widely. It is thought that patients who decline may be at higher risk for HIV infection, thus we sought to better understand patient acceptance and refusal of ED HIV testing.
In-depth interviews with fifty ED patients (28 accepters and 22 decliners of HIV testing) in three ED HIV testing programs that serve vulnerable urban populations in northern California.
Many factors influenced the decision to accept ED HIV testing, including curiosity, reassurance of negative status, convenience, and opportunity. Similarly, a number of factors influenced the decision to decline HIV testing, including having been tested recently, the perception of being at low risk for HIV infection due to monogamy, abstinence or condom use, and wanting to focus on the medical reason for the ED visit. Both accepters and decliners viewed ED HIV testing favorably and nearly all participants felt comfortable with the testing experience, including the absence of counseling. While many participants who declined an ED HIV test had logical reasons, some participants also made clear that they would prefer not to know their HIV status rather than face psychosocial consequences such as loss of trust in a relationship or disclosure of status in hospital or public health records.
Testing for HIV in the ED as for any other health problem reduces barriers to testing for some but not all patients. Patients who decline ED HIV testing may have rational reasons, but there are some patients who avoid HIV testing because of psychosocial ramifications. While ED HIV testing is generally acceptable, more targeted approaches to testing are necessary for this subgroup.
Emergency department; HIV testing; HIV test refusal; HIV test acceptance
The 2006 Centers for Disease Control and Prevention (CDC) HIV testing guidelines recommend screening for HIV infection in all healthcare settings, including the emergency department (ED). In urban areas with a high background prevalence of HIV, the ED has become an increasingly important site for identifying HIV infection. However, this public health policy has been operationalized using different models. We sought to describe the development and implementation of HIV testing programs in three EDs, assess factors shaping the adoption and evolution of specific program elements, and identify barriers and facilitators to testing.
We performed a qualitative evaluation using in-depth interviews with fifteen 'key informants' involved in the development and implementation of HIV testing in three urban EDs serving sizable racial/ethnic minority and socioeconomically disadvantaged populations. Testing program HIV prevalence ranged from 0.4% to 3.0%.
Three testing models were identified, reflecting differences in the use of existing ED staff to offer and perform the test and disclose results. Factors influencing the adoption of a particular model included: whether program developers were ED providers, HIV providers, or both; whether programs took a targeted or non-targeted approach to patient selection; and the extent to which linkage to care was viewed as the responsibility of the ED. A common barrier was discomfort among ED providers about disclosing a positive HIV test result. Common facilitators were a commitment to underserved populations, the perception that testing was an opportunity to re-engage previously HIV-infected patients in care, and the support and resources offered by the medical setting for HIV-infected patients.
ED HIV testing is occurring under a range of models that emerge from local realities and are tailored to institutional strengths to optimize implementation and overcome provider barriers.
Relationships between mental health symptoms (anxiety and depression) or a positive state of mind and behavior associated with HIV transmission (substance use and risky sexual behavior) were explored in a longitudinal study on persons living with HIV (PLH; n = 936) who were participants in a transmission-prevention trial. Bivariate longitudinal regressions were used to estimate the correlations between mental health symptoms and HIV-related transmission acts for three time frames: at the baseline interview; over 25 months; and from assessment to assessment. At baseline, mental health symptoms were associated with transmission acts. Elevated levels of mental health symptoms at baseline were associated with decreasing alcohol or marijuana use over 25 months. Over 25 months, an increasingly positive state of mind was associated with decreasing alcohol or marijuana use; an increasingly positive state of mind in the immediate condition and increasing depressive symptoms in the lagged condition were related to increasing risky sexual behavior. Our findings suggest that mental health symptoms precede a decrease in substance use and challenge self-medication theories. Changes in mental health symptoms and sexual behavior occur more in tandem.
HIV; Mental Health; Depression; Anxiety; Substance Abuse; Sexual behavior
Acute/early HIV infection is a period of high risk for HIV transmission. Better understanding of behavioral aspects during this period could improve interventions to limit further transmission. Thirty-four participants with acute/early HIV infection from six U.S. cities were assessed with the Mini International Diagnostic Interview, Beck Depression Inventory II, State-Trait Anxiety Inventory, Brief COPE, and an in-depth interview. Most had a pre-HIV history of alcohol or substance use disorder (85%); a majority (53%) had a history of major depressive or bipolar disorder. However, post-diagnosis coping was predominantly adaptive, with only mild to moderate elevations of anxious or depressive mood. Respondents described challenges managing HIV in tandem with pre-existing substance abuse problems, depression, and anxiety. Integration into medical and community services was associated with adaptive coping. The psychiatric context of acute/early HIV infection may be a precursor to infection, but not necessarily a barrier to intervention to reduce forward transmission of HIV among persons newly infected.
Acute HIV infection; psychiatric disorder; substance use disorder; coping
Risk reductions behaviors are especially important during acute/early HIV infection, a period of high transmission risk. We examined how sexual behaviors changed following diagnosis of acute/early HIV infection. Twenty-eight individuals completed structured surveys and in-depth interviews shortly after learning of their infection and two months later. Quantitative analyses revealed significant changes after diagnosis, including reductions in total partners and decreases in the proportion of unprotected sex acts occurring with uninfected partners (serosorting). Qualitative findings indicated that these changes were motivated by concerns about infecting others. However, participants were less successful at increasing the frequency with which they used condoms. These results suggest that the initial diagnosis with HIV may constitute an important component of interventions to promote risk reduction during the acute/early stages of the disease.
acute HIV; serosorting; behavior change; HIV prevention
Acute/early HIV infection plays a critical role in onward HIV transmission. Detection of HIV infections during this period provides an important early opportunity to offer interventions which may prevent further transmission. In six U.S. cities, persons with acute/early HIV infection were identified using either HIV RNA testing of pooled sera from persons screened HIV antibody negative or through clinical referral of persons with acute or early infections. Fifty-one cases were identified and 34 (68%) were enrolled into the study; 28 (82%) were acute infections and 6 (18%) were early infections. Of those enrolled, 13 (38 %) were identified through HIV pooled testing of 7,633 HIV antibody negative sera and 21 (62%) through referral. Both strategies identified cases that would have been missed under current HIV testing and counseling protocols. Efforts to identify newly infected persons should target specific populations and geographic areas based on knowledge of the local epidemiology of incident infections.
Acute HIV infection; nucleic acid amplification tests; HIV RNA testing; early detection of acute HIV infection
Acute/early HIV infection is a period of high HIV transmission. Consequently, early detection of HIV infection and targeted HIV prevention could prevent a significant proportion of new transmissions. As part of an NIMH-funded multisite study, we used in-depth interviews to explore understandings of acute HIV infection (AHI) among 34 individuals diagnosed with acute/early HIV infection in six U.S. cities. We found a marked lack of awareness of AHI-related acute retroviral symptoms and a lack of clarity about AHI testing methods. Most participants knew little about the meaning and/or consequences of AHI, particularly that it is a period of elevated infectiousness. Over time and after the acute stage of infection, many participants acquired understanding of AHI from varied sources, including the Internet, HIV-infected friends, and health clinic employees. There is a need to promote targeted education about AHI to reduce the rapid spread of HIV associated with acute/early infection within communities at risk for HIV.
HIV/AIDS; Awareness; Acute HIV; HIV prevention
Acute/early HIV infection is a period of heightened HIV transmission and a window of opportunity for intervention to prevent onward disease transmission. The NIMH Multisite Acute HIV Infection (AHI) Study was an exploratory initiative aimed at determining the feasibility of recruiting persons with AHI into research, assessing their psychosocial and behavioral characteristics, and examining short-term changes in these characteristics. This paper reports on lessons learned in the study, including: (1) the need to establish the cost-effectiveness of AHI testing; (2) challenges to identifying persons with AHI; (3) the need to increase awareness of acute-phase HIV transmission risks; (4) determining the goals of behavioral interventions following AHI diagnosis; and (5) the need for “rapid response” public health systems that can move quickly enough to intervene while persons are still in the AHI stage. There are untapped opportunities for behavioral and medical science collaborations in these areas that could reduce the incidence of HIV infection.
Acute HIV infection; HIV prevention; Public health
To support expanded prevention services for people living with HIV, the US Health Resources and Services Administration (HRSA) sponsored a 5-year initiative to test whether interventions delivered in clinical settings were effective in reducing HIV transmission risk among HIV-infected patients. Across 13 demonstration sites, patients were randomized to one of four conditions. All interventions were associated with reduced unprotected vaginal and/or anal intercourse with persons of HIV-uninfected or unknown status among the 3,556 participating patients. Compared to the standard of care, patients assigned to receive interventions from medical care providers reported a significant decrease in risk after 12 months of participation. Patients receiving prevention services from health educators, social workers or paraprofessional HIV-infected peers reported significant reduction in risk at 6 months, but not at 12 months. While clinics have a choice of effective models for implementing prevention programs for their HIV-infected patients, medical provider-delivered methods are comparatively robust.
HIV Prevention with positives; Clinic-based HIV prevention; HIV risk reduction; Interventions; Study outcomes
Disparities in the use of antiretroviral therapy (ART) for HIV disease have been documented across race, gender, and substance use groups.
The current analysis compares self-reported reasons for never taking or stopping ART among a diverse sample of men and women living with HIV.
HIV + (N = 3,818) adults, 968 of whom reported discontinuing or never using ART.
Computerized self-administered and interviewer-administered self-reported demographic and treatment variables, including gender, race, ethnicity, CD4 count, detectable viral load, and reported reasons for not taking antiretroviral therapy.
Despite equivalent use of ART in the current sample, African-American respondents were 1.7 times more likely to report wanting to hide their HIV status and 1.7 times more likely to report a change in doctors/clinics as reasons for stopping ART (p = .049, and p = .042) and had odds 4.5 times those of non-African Americans of reporting waiting for viral marker counts to worsen (p = < .0001). There was a lower tendency (OR = 0.4) for women to endorse concerns of keeping their HIV status hidden as a reason for stopping ART compared to men (p = .003). Although those with an IDU history were less likely to be on ART, no differences in reasons for stopping or never initiating ART were found between those with and without an IDU history.
A desire to conceal HIV status as well as a change in doctors/clinics as reasons for discontinuing ART were considerably more common among African Americans, suggesting that perceived HIV/AIDS stigma is an obstacle to maintenance of treatment. Findings also indicate differences in reasons for stopping ART by gender and a perceived desire to wait for counts to worsen as a reason for not taking ART by African Americans, regardless of detectable viral load, CD4 count, age, education, employment, sexual orientation, and site.
HIV/AIDS; treatment disparities; gender; race; ethnicity; substance use
Internalized heterosexism (IH), or the internalization of societal anti-homosexual attitudes, has been consistently linked to depression and low self-esteem among gay men, and inconclusively associated with substance use and sexual risk in gay and bisexual men. Using structural equation modeling, a model framed in Social Action Theory was tested in which IH is associated with HIV transmission risk and poor adherence to HIV antiretroviral therapy (ART) through the mechanisms of negative affect and stimulant use. Data from a sample of 465 gay-identified men interviewed as part of an HIV risk reduction behavioral trial were used to test the fit of the model. Results supported the hypothesized model in which IH was associated with unprotected receptive (but not insertive) anal intercourse with HIV-negative or unknown HIV status partners, and with ART non-adherence indirectly via increased negative affect and more regular stimulant use. The model accounted for 15% of the variance in unprotected receptive anal intercourse (URAI) and 17% of the variance in ART non-adherence. Findings support the potential utility of addressing IH in HIV prevention and treatment with HIV-positive gay men.
HIV/AIDS; internalized heterosexism; homophobia; adherence; depression; methamphetamine; HIV transmission risk
Changing community norms to increase awareness of HIV status and reduce HIV-related stigma has the potential to reduce the incidence of HIV-1 infection in the developing world.
We developed and implemented a multi-level intervention providing community-based HIV mobile voluntary counseling and testing (CBVCT), community mobilization (CM), and post-test support services (PTSS). Forty-eight communities in Tanzania, Zimbabwe, South Africa and Thailand were randomized to receive the intervention or standard clinic-based VCT (SVCT), the comparison condition. We monitored utilization of CBVCT and SVCT by community of residence at 3 sites, which was used to assess differential uptake. We also developed Quality Assurance procedures to evaluate staff fidelity to the intervention.
In the first year of the study a four-fold increase in testing was observed in the intervention versus comparison communities. We also found an overall 95% adherence to intervention components. Study outcomes, including prevalence of recent HIV infection and community-level HIV stigma, will be assessed after three years of intervention.
The provision of mobile services, combined with appropriate support activities, may have significant effects on utilization of VCT. These findings also provide early support for community mobilization as a strategy for increasing testing rates.
HIV prevention; HIV voluntary counseling and testing; community mobilization; post-test support services; HIV-related stigma
Acute/early HIV infection is a period of high risk for HIV transmission. Better understanding of behavioral aspects during this period could improve interventions to limit further transmission. Thirty-four participants with acute/early HIV infection from six US cities were assessed with the Mini International Diagnostic Interview, Beck Depression Inventory II, State-Trait Anxiety Inventory, Brief COPE, and an in-depth interview. Most had a pre-HIV history of alcohol or substance use disorder (85%); a majority (53%) had a history of major depressive or bipolar disorder. However, post-diagnosis coping was predominantly adaptive, with only mild to moderate elevations of anxious or depressive mood. Respondents described challenges managing HIV in tandem with pre-existing substance abuse problems, depression, and anxiety. Integration into medical and community services was associated with adaptive coping. The psychiatric context of acute/early HIV infection may be a precursor to infection, but not necessarily a barrier to intervention to reduce forward transmission of HIV among persons newly infected.
Acute HIV infection; Psychiatric disorder; Substance use disorder; Coping
Risk reductions behaviors are especially important during acute/early HIV infection, a period of high transmission risk. We examined how sexual behaviors changed following diagnosis of acute/early HIV infection. Twenty-eight individuals completed structured surveys and in-depth interviews shortly after learning of their infection and 2 months later. Quantitative analyses revealed significant changes after diagnosis, including reductions in total partners and decreases in the proportion of unprotected sex acts occurring with uninfected partners (serosorting). Qualitative findings indicated that these changes were motivated by concerns about infecting others. However, participants were less successful at increasing the frequency with which they used condoms. These results suggest that the initial diagnosis with HIV may constitute an important component of interventions to promote risk reduction during the acute/early stages of the disease.
Acute HIV; Serosorting; Behavior change; HIV prevention
To examine factors that explain the effect of a cognitive-behavioral intervention on reductions in HIV transmission risk among HIV-infected men who have sex with men (MSM).
Of the 1,910 HIV-infected MSM screened, 616 participants considered to be at risk of transmitting HIV were randomized to a 15-session, individually delivered cognitive-behavioral intervention (n = 301) or a wait-list control (n = 315).
Consistent with previous intent-to-treat findings, there was an overall reduction in transmission risk acts among MSM in both intervention and control arms, with significant intervention effects observed at the 5, 10, 15, and 20 month assessments (Risk Ratios = .78, .62, .48, and .38, respectively). These intervention-related decreases in HIV transmission risk acts appeared to be partially due to sustained serosorting practices. MSM in the intervention condition reported a significantly greater proportion of sexual partners who were HIV-infected at the 5 and 10 month assessments (Risk Ratio = 1.14 and 1.18).
The Healthy Living Project, a cognitive-behavioral intervention, is efficacious in reducing transmission risk acts among MSM. This appears to have been due in large part to the fact that MSM in the intervention condition reported sustained serosorting practices.
Men Who Have Sex with Men; Prevention with Positives; Randomized Controlled Trial; Prevention Case Management
Recruiting and retaining high-risk individuals is critical for HIV prevention trials.
The current analyses addressed predictors of trial dropout among high-risk HIV-infected men and women.
Trial dropouts (n=74) were more likely to be younger, depressed, and not taking antiretroviral therapy than those who continued (n=815). No other background, substance use, or transmission risk differences were found, suggesting no dropout bias on key risk outcomes.
Efforts are warranted for early detection and treatment of depression and for improving retention of younger participants.
Clinical Trials; Prevention; Retention; Depression
To examine the effect of a 15-session, individually delivered cognitive behavioral intervention on antiretroviral (ART) medication adherence.
A multisite, two-group, randomized controlled trial.
204 HIV-infected participants with self-reported ART adherence < 85% out of 3,818 screened were randomized into the trial. Potential participants were recruited for the main trial based on sexual risk criteria in Los Angeles, Milwaukee, New York, and San Francisco.
The primary outcome of the intervention was a reduction in HIV transmission risk behaviors. Fifteen 90-minute individually delivered sessions divided into three modules: Stress, Coping, and Adjustment; Safer Behaviors; and Health Behaviors, including an emphasis on ART adherence. Controls received no intervention until trial completion. Both groups completed follow-up assessments at 5, 10, 15, 20, and 25 months after randomization.
Main Outcome Measure
Self-reported ART adherence as measured by 3 day computerized assessment.
A significance difference in rates of reported adherence was observed between intervention and control participants at months 5 and 15, corresponding to the assessments following Stress, Coping and Adjustment module (5 month time point) and after the Health Behaviors module (15 month time point). The relative improvements among the intervention group compared to the control group dissipated at follow up.
Cognitive behavioral intervention programs may effectively improve ART adherence, but the effects of intervention may be short-lived.
Antiretroviral therapy; adherence; compliance; RCT
HIV medication adherence remains a challenge and limits the degree to which treatment benefit can be maximized. The purpose of this paper is to test an explanatory model of HIV medication adherence using a social problem-solving (SPS) framework. Associations of SPS with adherence are hypothesized to be direct and/or indirect via psychological health. HIV+ adults were interviewed using validated measures of SPS, psychological health, and antiretroviral (ART) medication adherence. Structural equation modeling (SEM) techniques were employed to test hypothesized relationships and to evaluate overall fit of the model to the data. SEM supported an indirect association (but not direct) of SPS on adherence via psychological health among the 545 HIV+ adults included in the analyses. Overall, the findings resulted in a model of adherence that offered very good fit to the data and correctly classified 97% of the cases as adherent versus non-adherent. Results support the use of SPS as a conceptual framework for understanding adherence to ART. Findings offer rationale and direction for SPS interventions to enhance adherence by improving psychological health. Such approaches, if effective, have the potential to positively impact psychological well being and adherence, thereby maximizing clinical benefit from treatment, which is linked to lower mortality from AIDS.
Social Problem-Solving; HIV; AIDS; Adherence; Compliance; Psychological Distress; Structural Equation Modeling