Contraception methods used among women with HIV starting antiretroviral therapy in a large United States clinical trial, 2009-2011.

OBJECTIVE(S): We describe contraception and dual method use among women with HIV initiating antiretroviral therapy (ART) in a U.S. clinical trial and examine associated factors. STUDY DESIGN: We analyzed data from ART-naïve women aged 45 years and under initiating one of 3 regimens as part of A5257 (May 2009-June 2011) which required that women at risk for pregnancy use contraception. We classified self-reported methods as more effective (Tier 1 [intrauterine device, hysterectomy, permanent contraception] and Tier 2 [hormonal rings, patches, injections, pills]) versus less effective (Tier 3 [condoms alone] and Tier 4 [withdrawal, none]). We used logistic regression models to assess associations with use of (a) more effective, and (b) dual methods (condoms with a more effective method). RESULTS: Of 285 women, majority were Black (59%), had annual income <$20,000 (54%), and had government insurance (68%). The most common contraceptive methods reported at baseline were permanent contraception (37%), male condoms alone (31%), and injectable progestin (8%); 41% and 16% reported Tier 1 and 2 use, respectively; 36% reported dual method use. Use of more effective and dual methods did not change 48 and 96 weeks after ART initiation (p > 0.05). In multivariable analyses, baseline use of more effective and dual methods was associated with age at least 40 years versus 18 to 29 years (odds ratio [OR] 4.46, 95% confidence interval [CI] 2.12, 9.35) and having at least one child (OR 2.31, 95%CI 1.27, 4.20). CONCLUSIONS: In women initiating modern ART in a clinical trial, permanent contraception was common, while use of other more effective contraceptive methods was low and did not change after ART initiation. Efforts are needed to improve integration of family planning services for women within the context of HIV clinical trials. IMPLICATIONS: The findings highlight the importance of improving integration of HIV and family planning services, including in the context of clinical trials.

Metabolic Changes Associated With the Use of Integrase Strand Transfer Inhibitors Among Virally Controlled Women.

BACKGROUND: Integrase strand transfer inhibitors (INSTIs) have been associated with weight gain among women living with HIV. We aimed to investigate the association between INSTIs and change in cardiometabolic risk indicators. SETTING: Retrospective cohort. METHODS: Data from 2006 to 2017 were analyzed from women living with HIV enrolled in the longitudinal Women's Interagency HIV Study who were virally controlled on antiretroviral therapy (ART) for ≥5 consecutive semiannual visits. Women who switched/added an INSTI to ART (INSTI group) were compared with women who remained on non-INSTI ART (non-INSTI group). Outcomes included changes in fasting lipids and glucose, hemoglobin A1c (HbA1c), blood pressure (BP), and incident diabetes, hypertension, and insulin resistance. Outcomes were measured 6-12 months before and 6-18 months after INSTI switch/add in the INSTI group with comparable visits in the non-INSTI group. Longitudinal linear regression models compared change over time in each outcome by the study group. RESULTS: One thousand one hundred eighteen participants (234 INSTI, 884 non-INSTI) were followed for a median 2.0 (Q1 1.9, Q3 2.0) years. Participants were median age 49 years, 61% Black, and 73% overweight or obese (body mass index ≥25 kg/m). Compared with non-INSTI, the INSTI group experienced greater increases in HbA1c (+0.05 vs. -0.06 mg/dL, P = 0.0318), systolic BP (+3.84 vs. +0.84 mm Hg, P = 0.0191), and diastolic BP (+1.62 vs. -0.14 mm Hg, P = 0.0121), with greatest change in HbA1c among women on INSTIs with ≥5% weight gain. CONCLUSIONS: INSTI use was associated with unfavorable changes in HbA1c and systolic and diastolic BP during short-term follow-up. Further research is needed to understand long-term cardiometabolic effects of INSTI use.

Weight Gain Associated With Integrase Stand Transfer Inhibitor Use in Women.

BACKGROUND: Integrase strand-transfer inhibitor (INSTI)-based antiretroviral therapy (ART) is recommended for human immunodeficiency virus (HIV) management. Although studies have suggested associations between INSTIs and weight gain, women living with HIV (WLHIV) have been underrepresented in research. We evaluated the effect of switching or adding INSTIs among WLHIV. METHODS: Women enrolled in the Women's Interagency HIV Study (WIHS) from 2006-2017 who switched to or added an INSTI to ART (SWAD group) were compared to women on non-INSTI ART (STAY group). Body weight, body mass index (BMI), percentage body fat (PBF), and waist, hip, arm, and thigh circumferences were measured 6-12 months before and 6-18 months after the INSTI switch/add in SWAD participants, with comparable measurement time points in STAY participants. Linear regression models compared changes over time by SWAD/STAY group, adjusted for age, race, WIHS site, education, income, smoking status, and baseline ART regimen. RESULTS: We followed 1118 women (234 SWAD and 884 STAY) for a mean of 2.0 years (+/- 0.1 standard deviation [SD]; mean age 48.8 years, SD +/- 8.8); 61% were Black. On average, compared to the STAY group, the SWAD group experienced mean greater increases of 2.1 kg in body weight, 0.8 kg/m2 in BMI, 1.4% in PBF, and 2.0, 1.9, 0.6, and 1.0 cm in waist, hip, arm, and thigh circumference, respectively (all P values < .05). No differences in magnitudes of these changes were observed by INSTI type. CONCLUSIONS: In WLHIV, a switch to INSTI was associated with significant increases in body weight, body circumferences, and fat percentages, compared to non-INSTI ART. The metabolic and other health effects of these changes deserve further investigation.

Health Information Exchange: A Novel Re-linkage Intervention in an Urban Health System.

BACKGROUND: Public health information exchanges (HIEs) link real-time surveillance and clinical data and can help to re-engage out-of-care people with HIV (PWH). METHODS: We conducted a retrospective cohort study of out-of-care PWH who generated an HIE alert in the Grady Health System (GHS) Emergency Department (ED) between January 2017 and February 2018. Alerts were generated for PWH who registered in the GHS ED without Georgia Department of Public Health (GDPH) CD4 or HIV-1 RNA in the prior 14 months. The alert triggered a social work (SW)-led re-linkage effort. Multivariate logistic regression analyses used HIE-informed SW re-linkage efforts as the independent variable, and linkage to care and 3- and 6-month viral suppression (HIV-1 RNA < 200 c/mL) as primary outcomes. Patients admitted to the hospital were excluded from primary analysis. RESULTS: One hundred forty-seven out-of-care patients generated an alert. Ninety-eight were included in the primary analysis (mean age [SD], 41 ± 12 years; 70% male; 93% African American), and 20 received the HIE-informed SW intervention. Sixty percent of patients receiving the intervention linked to care in 6 months, compared with 35% who did not. Patients receiving the intervention were more likely to link to care (adjusted risk ratio [aRR], 1.63; 95% confidence interval [CI], 0.99-2.68) and no more likely to achieve viral suppression (aRR, 1.49; 95% CI, 0.50-4.46) than those who did not receive the intervention. CONCLUSIONS: An HIE-informed, SW-led intervention systematically identified out-of-care PWH and may increase linkage to care for this important population. HIEs create an opportunity to intervene with linkage and retention strategies.