Cheng-Shiun Leu

Longitudinal study of mental health and psychosocial predictors of medical treatment adherence in mothers living with HIV disease.

Cross-sectional studies to date that examine psychosocial correlates of antiretroviral adherence have insufficiently addressed the challenges of long-term adherence. This longitudinal study examined mental health, substance abuse, and psychosocial predictors of long-term adherence to antiretroviral medications and medical appointments among HIV-seropositive mothers recruited from an infectious disease clinic of a large urban medical center. Individual interviews were conducted at baseline and two follow-up points, 8 to 18 months after enrollment. Based on a model of health behavior, we examined psychiatric and psychosocial predictors of adherence to antiretroviral medications and medical appointments over time. Presence of a psychiatric disorder, negative stressful life events, more household members, and parenting stress were significantly associated with both missed pills and missed medical appointments at follow-up. Baseline substance abuse was associated with missed pills at follow-up and lack of disclosure to family members at baseline was associated with missed medical appointments at follow-up. These findings suggest that interventions that integrate mental health, substance abuse and medical care may be important to improving the medical adherence and health of HIV-seropositive women, particularly in multistressed populations with substantial caregiving and other life demands.

A gender-specific HIV/STD risk reduction intervention for women in a health care setting: Short- and long-term results of a randomized clinical trial

This study assessed the short- and long-term effect of a gender-specific group intervention for women on unsafe sexual encounters and strategies for protection against HIV/STD infection. Family planning clients (N = 360) from a high HIV seroprevalence area in New York City were randomized to an eight-session, a four-session or a control condition and followed at one, six and 12 months post-intervention. Using an intention-to-treat analysis, women who were assigned to the eight-session group had about twice the odds of reporting decreased or no unprotected vaginal and anal intercourse compared to controls at one month (OR = 1.93, 95% confidence interval [CI] = 1.07, 3.48, p = 0.03) and at 12-month follow-up (OR = 1.65, 95% CI = 0.94, 2.90, p = 0.08). Relative to controls, women assigned to the eight-session condition reported during the previous month approximately three-and-a-half (p = 0.09) and five (p < 0.01) fewer unprotected sex occasions at one- and 12-month follow-up, respectively. Women in the eight-session group also reduced the number of sex occasions at both follow-ups, and had a greater odds of first time use of an alternative protective strategy (refusal, outercourse, mutual testing) at one-month follow-up. Results for the four-session group were in the expected direction but overall were inconclusive. Thus, gender-specific interventions of sufficient intensity can promote short- and long-term sexual risk reduction among women in a family planning setting.

Rates and types of psychiatric disorders in perinatally human immunodeficiency virus-infected youth and seroreverters.

BACKGROUND The purpose of this study was to examine 1) the prevalence of psychiatric and substance use disorders in perinatally HIV-infected (HIV+) adolescents and 2) the association between HIV infection and these mental health outcomes by comparing HIV+ youths to HIV exposed but uninfected youths (HIV-) from similar communities. METHODS Data for this paper come from the baseline interview of a longitudinal study of mental health outcomes in 9-16 year old perinatally HIV-exposed youths (61% HIV+) and their caregivers. Three hundred forty youths and their primary adult caregivers were recruited from four medical centers and participated in separate individual interviews. Youth psychiatric disorder was assessed using the caregiver and youth versions of The Diagnostic Interview Schedule for Children (DISC-IV). RESULTS According to caregiver or youth report, a high percentage of HIV+ and HIV- youths met criteria for a non-substance use psychiatric disorder, with significantly higher rates among the HIV+ youths (61% vs. 49%, OR = 1.59; CI = 1.03,2.47; p < .05). The most prevalent diagnoses in both groups were anxiety disorders (46% for total sample) which included social phobia, separation anxiety, agoraphobia, generalized anxiety disorder, panic disorder, obsessive- compulsive disorder, and specific phobias. One quarter of the sample met criteria for a behavioral disorder (ADHD, conduct disorders, and oppositional defiant disorders), with ADHD being most prevalent. HIV+ youths had significantly higher rates of ADHD (OR = 2.45; CI = 1.20, 4.99, p < .05). Only 7% of youths met criteria for a mood disorder and 4% for a substance abuse disorder. Several caregiver variables (caregiver type and HIV status) were also associated with both child HIV status and mental health outcomes. CONCLUSIONS Our data suggest that HIV+ youths are at high risk for mental health disorders. Further longitudinal research is necessary to understand the etiology, as well as potential protective factors, in order to inform efficacy-based interventions.

Clinical relative biological effectiveness of low-energy x-rays emitted by miniature x-ray devices

Several groups are developing ultra-miniature x-ray machines for clinical use in radiation therapy. Current systems are for interstitial radiosurgery and for intravascular insertion for irradiation to prevent re-stenosis. Typical generating voltages are low, in the 20 to 40 kV range. It is well established that the biological effectiveness of such low-energy photons is large compared with higher-energy gamma rays, because of the dominance of photoelectric absorption at low energies. We have used microdosimetric analyses to estimate RBEs for such devices, both at low doses and clinically relevant doses, relative to radiations from 60Co, 192Ir, 125I and 90Sr/90Y. The RBEs at clinically relevant doses and dose rates for these low-energy x-ray sources are considerably above unity, both relative to 60Co and to 192Ir photons, and also relative to 125I and 90Sr/90Y brachytherapy sources. As a function of depth, the overall effect of the change in dose and the change in beam spectrum results in beams whose biologically weighted dose (dose x RBE) decreases with depth somewhat more slowly than does the physical dose. The estimated clinically relevant RBEs are sufficiently large that they should be taken into account during the treatment design stage.

Intimate Partner Violence and Safer Sex Negotiation: Effects of a Gender-Specific Intervention

This study examined the effects of a gender-specific HIV/STD prevention intervention with two dosage levels (four-session, eight-session) among women reporting physical abuse by a current or recent (past year) intimate partner. From 360 women included in the full randomized trial, we conducted subgroup analyses among 152 women who experienced partner physical abuse within the past year. Unprotected vaginal and anal sex occasions and negotiation skills were examined as outcomes. We also assessed whether the intervention increased previously abused womens subsequent risk of physical abuse. Among abused women, those in the eight-session, but not the four-session, intervention decreased their unprotected sex occasions or maintained consistent safer sex at both 1-month (OR = 3.63, 95% CI = 1.50–8.80) and 1-year (OR = 2.88, 95% CI = 1.17–7.10) postintervention. In the short-term, abused women in both the four- and eight-session groups had a greater odds of using an alternative strategy (e.g., refusal, “outercourse,” or mutual testing) and of having a safer sex discussion with their partners relative to their controls, and they scored higher on intention to negotiate safer sex. The intervention did not increase or decrease the incidence of subsequent abuse during the 1-year follow-up period. A gender-specific intervention that focuses on negotiation skills in the context of potentially abusive partners benefits, and does not appear to harm, recently abused women.

A randomized controlled trial to test an HIV-prevention intervention for Latino gay and bisexual men: lessons learned.

At the time of this writing, no randomized controlled trial (RCT) of an intervention to reduce unsafe sex among Latino gay and bisexual men (LGBM) had been published. We report the results of an RCT conducted in New York City in which 180 LGBM were assigned either to an intervention developed specifically for this population or to a wait-list control group. The intervention was based on empowerment theory and used factors identified in prior research as determinants of unsafe sex. By eligibility criteria, all men had engaged in unprotected anal intercourse (UAI) within two months of the baseline assessment. At first (two months) and second (six months later) follow-up assessments, approximately half of the men in the experimental group reported no UAI. Yet, a similar proportion of the control group also reported no UAI. Baseline data indicate that although the men had been the subject of social oppression and sexual prejudice (homophobia), they did not feel disempowered, externally controlled or fatalistic, and they reported self-efficacy and intentionality to enact safer sex. Lessons learned are discussed, as well as notes of caution for future research employing a similar conceptual framework.

The VUKA family program: Piloting a family-based psychosocial intervention to promote health and mental health among HIV infected early adolescents in South Africa

An increasing number of adolescents born with HIV in South Africa are on antiretroviral treatment and have to confront complex issues related to coping with a chronic, stigmatizing and transmittable illness. Very few evidence-based mental health and health promotion programs for this population exist in South Africa. This study builds on a previous collaboratively designed and developmentally timed family-based intervention for early adolescents (CHAMP). The study uses community-based participatory approach as part of formative research to evaluate a pilot randomized control trial at two hospitals. The paper reports on the development, feasibility, and acceptability of the VUKA family-based program and its short-term impact on a range of psychosocial variables for HIV + preadolescents and their caregivers. A 10-session intervention of approximately 3-month duration was delivered to 65 preadolescents aged 10–13 years and their families. VUKA participants were noted to improve on all dimensions, including mental health, youth behavior, HIV treatment knowledge, stigma, communication, and adherence to medication. VUKA shows promise as a family-based mental and HIV prevention program for HIV + preadolescents and which could be delivered by trained lay staff.

Prevalence and change in psychiatric disorders among perinatally HIV-infected and HIV-exposed youth

Abstract As the pediatric HIV epidemic in resource-rich countries evolves into an adolescent epidemic, there is a substantive need for studies elucidating mental health needs of perinatally HIV-infected (PHIV + ) youth as they transition through adolescence. This article examines the role of perinatal HIV infection in influencing mental health by comparing the changes in psychiatric disorders and substance use disorders (SUD) in PHIV + and perinatally HIV-exposed, but uninfected (PHIV − ) youth over time. Participants were recruited from four medical centers in New York City. Individual interviews were administered at baseline and 18-month follow-up to 166 PHIV + and 114 PHIV– youth (49% male, age 9–16 years at baseline). Youth psychiatric disorder was assessed using the caregiver and youth versions of the Diagnostic Interview Schedule for Children (DISC-IV). Over two-thirds of participants met criteria for at least one psychiatric disorder at either baseline or follow-up, with few group differences. Among PHIV + youth, there was a significant decrease in the prevalence of any psychiatric disorder, as well as anxiety disorders specifically over time, whereas the prevalence of any psychiatric disorder among PHIV– youth remained the same and mood disorders increased. Rates of SUD were low in both groups, increasing slightly by follow-up. PHIV + youth reported more use of mental health services at follow-up. CD4 count and HIV RNA viral load were not associated with the presence or absence of disorder at either time point. In conclusion, among PHIV + and PHIV− youth, the rates of psychiatric disorder were high, even compared to other vulnerable populations, suggesting that factors other than perinatal HIV infection may be important determinants of mental health. PHIV + youth were more likely to improve over the observation period. The data underscore the critical need for mental health interventions for both PHIV + and PHIV− youth.

Female-condom use in a gender-specific family planning clinic trial.

OBJECTIVES We evaluated female-condom use among women participating in an HIV/STD intervention designed to reduce unprotected sex and expand prevention strategies. METHODS Women (n = 360) were recruited from a family-planning clinic and were randomized into an 8- or 4-session intervention group or a control group. We conducted follow-up interviews at 1, 6, and 12 months. RESULTS At 1 month, the odds ratios of first-time female-condom use were 9.49 (95% confidence interval [CI] = 4.01, 22.20) in the 8-session group and 4.39 (95% CI = 1.84, 10.49) in the 4-session group relative to controls. Repeated use (n = 21) was predicted by perceived ability to use, by self and partner satisfaction, by dislike of male condoms, and by previous diaphragm use. CONCLUSIONS Gender sensitive cognitive-behavioral interventions can influence women to try the female condom. To increase long-term use, interventions may need to include self-insertion practice and involvement of male partners.

Hepatitis B virus and human immunodeficiency virus drugs in pregnancy: Findings from the Antiretroviral Pregnancy Registry

BACKGROUND & AIMS Fetal safety of antiviral therapies is important given the long-term treatment of women with chronic hepatitis B (CHB) infection who may become pregnant. We analyzed neonatal safety data from the Antiretroviral Pregnancy Registry (APR), the largest safety database in pregnancy for antivirals used for HIV and CHB. METHODS Data were extracted from APR cases prospectively enrolled between 1989 and 2011. Primary outcomes were major birth defects rates with exposure to all antivirals, individual classes, and drugs compared to population-based controls. Relevant to CHB, only lamivudine (LAM) and tenofovir disoproxil fumarate (TDF) had sufficient individual data for review (≥200 cases). RESULTS Of 13,711 cases analyzed, the overall birth defect prevalence (2.8%, 95% CI 2.6-3.1%) was comparable to Centers for Disease Control population-based data (2.72%, 2.68-2.76%, p=0.87) and two prospective antiretroviral exposed newborn cohorts (2.8%, 2.5-3.2%, p=0.90 and 1.5%, 1.1-2.0%, p<0.001). The birth defects prevalence between first and second/third trimesters exposure was similar (3.0% vs. 2.7%). No increased risk of major birth defects with LAM or TDF exposure compared to population-based controls was observed. No specific pattern of major birth defects was observed for individual antivirals or overall. CONCLUSIONS No increased risk of major birth defects including in non-live births was observed for pregnant women exposed to antivirals relevant to CHB treatment overall or to LAM or TDF compared to population-based controls. Continued safety and efficacy reporting on antivirals in pregnancy are essential to inform patients on their risks and benefits during pregnancy.