Search

Importance: Home-based HIV testing is a frequently used strategy to increase awareness of HIV status in sub-Saharan Africa. However, with referral to health facilities, less than half of those who test HIV positive link to care and initiate antiretroviral therapy (ART)., Objective: To determine whether offering same-day home-based ART to patients with HIV improves linkage to care and viral suppression in a rural, high-prevalence setting in sub-Saharan Africa., Design, Setting, and Participants: Open-label, 2-group, randomized clinical trial (February 22, 2016-September 17, 2017), involving 6 health care facilities in northern Lesotho. During home-based HIV testing in 6655 households from 60 rural villages and 17 urban areas, 278 individuals aged 18 years or older who tested HIV positive and were ART naive from 268 households consented and enrolled. Individuals from the same household were randomized into the same group., Interventions: Participants were randomly assigned to be offered same-day home-based ART initiation (n = 138) and subsequent follow-up intervals of 1.5, 3, 6, 9, and 12 months after treatment initiation at the health facility or to receive usual care (n = 140) with referral to the nearest health facility for preparatory counseling followed by ART initiation and monthly follow-up visits thereafter., Main Outcomes and Measures: Primary end points were rates of linkage to care within 3 months (presenting at the health facility within 90 days after the home visit) and viral suppression at 12 months, defined as a viral load of less than 100 copies/mL from 11 through 14 months after enrollment., Results: Among 278 randomized individuals (median age, 39 years [interquartile range, 28.0-52.0]; 180 women [65.7%]), 274 (98.6%) were included in the analysis (137 in the same-day group and 137 in the usual care group). In the same-day group, 134 (97.8%) indicated readiness to start ART that day and 2 (1.5%) within the next few days and were given a 1-month supply of ART. At 3 months, 68.6% (94) in same-day group vs 43.1% (59) in usual care group had linked to care (absolute difference, 25.6%; 95% CI, 13.8% to 36.3%; P < .001). At 12 months, 50.4% (69) in the same-day group vs 34.3% (47) in usual care group achieved viral suppression (absolute difference, 16.0%; 4.4%-27.2%; P = .007). Two deaths (1.5%) were reported in the same-day group, none in usual care group., Conclusions and Relevance: Among adults in rural Lesotho, a setting of high HIV prevalence, offering same-day home-based ART initiation to individuals who tested positive during home-based HIV testing, compared with usual care and standard clinic referral, significantly increased linkage to care at 3 months and HIV viral suppression at 12 months. These findings support the practice of offering same-day ART initiation during home-based HIV testing., Trial Registration: clinicaltrials.gov Identifier: NCT02692027.

Importance: Antiretroviral treatment (ART) is now recommended for all HIV-positive persons. UNAIDS has set global targets to diagnose 90% of HIV-positive individuals, treat 90% of diagnosed individuals with ART, and suppress viral replication among 90% of treated individuals, for a population-level target of 73% of all HIV-positive persons with HIV viral suppression., Objective: To describe changes in the proportions of HIV-positive individuals with HIV viral suppression, HIV-positive individuals who had received a diagnosis, diagnosed individuals treated with ART, and treated individuals with HIV viral suppression, following implementation of a community-based testing and treatment program in rural East Africa., Design, Setting, and Participants: Observational analysis based on interim data from 16 rural Kenyan (n = 6) and Ugandan (n = 10) intervention communities in the SEARCH Study, an ongoing cluster randomized trial. Community residents who were 15 years or older (N = 77 774) were followed up for 2 years (2013-2014 to 2015-2016). HIV serostatus and plasma HIV RNA level were measured annually at multidisease health campaigns followed by home-based testing for nonattendees. All HIV-positive individuals were offered ART using a streamlined delivery model designed to reduce structural barriers, improve patient-clinician relationships, and enhance patient knowledge and attitudes about HIV., Main Outcomes and Measures: Primary outcome was viral suppression (plasma HIV RNA<500 copies/mL) among all HIV-positive individuals, assessed at baseline and after 1 and 2 years. Secondary outcomes included HIV diagnosis, ART among previously diagnosed individuals, and viral suppression among those who had initiated ART., Results: Among 77 774 residents (male, 45.3%; age 15-24 years, 35.1%), baseline HIV prevalence was 10.3% (7108 of 69 283 residents). The proportion of HIV-positive individuals with HIV viral suppression at baseline was 44.7% (95% CI, 43.5%-45.9%; 3464 of 7745 residents) and after 2 years of intervention was 80.2% (95% CI, 79.1%-81.2%; 5666 of 7068 residents), an increase of 35.5 percentage points (95% CI, 34.4-36.6). After 2 years, 95.9% of HIV-positive individuals had been previously diagnosed (95% CI, 95.3%-96.5%; 6780 of 7068 residents); 93.4% of those previously diagnosed had received ART (95% CI, 92.8%-94.0%; 6334 of 6780 residents); and 89.5% of those treated had achieved HIV viral suppression (95% CI, 88.6%-90.3%; 5666 of 6334 residents)., Conclusions and Relevance: Among individuals with HIV in rural Kenya and Uganda, implementation of community-based testing and treatment was associated with an increased proportion of HIV-positive adults who achieved viral suppression, along with increased HIV diagnosis and initiation of antiretroviral therapy. In these communities, the UNAIDS population-level viral suppression target was exceeded within 2 years after program implementation., Trial Registration: clinicaltrials.gov Identifier: NCT01864683.

Context: Current screening practices for blood donations have been successful in reducing human immunodeficiency virus (HIV) transmission through receipt of contaminated blood products. However, HIV-infected blood donations made prior to seroconversion and before high levels of viral replication occur could test negative using both serologic antigen and antibody tests. Testing based on nucleic acid amplification (NAT) is being implemented to screen for HIV-infected blood donated during this period, yet the issue of single vs minipool donation screening remains unresolved., Objectives: To determine HIV-1 genetic linkage between virus in 2 HIV-1-infected recipients of blood components and virus in the donor, who was HIV antigen and antibody negative at the time of donation; to screen the blood donor's plasma with HIV NAT assays, including those currently proposed for use in US blood donation screening., Design and Setting: Case study conducted in October 1997 involving the Communicable Disease Centre, Singapore General Hospital, and the Singapore Blood Transfusion Service, Singapore., Subjects: The blood donor and the 2 recipients of donor platelets and red blood cells., Main Outcome Measures: Genetic analysis of the HIV-1 p17 coding region of gag and the C2V5 region of env to determine the genetic relatedness of virus from the donor and recipients; reactivity in quantitative and qualitative assays, and reactivity in donor screening HIV NAT assays in single donation and minipool screening contexts., Results: Direct DNA sequencing demonstrated identical HIV-1 subtype E viral sequences in the donor and recipients. Based on comparisons of a qualitative and quantitative assay for HIV-1 RNA levels, a low level of viremia (range, 5-39 copies/mL in plasma) was estimated to be in the donor's undiluted blood at the time of donation. Additional testing using donor-screening NAT assays showed consistent detection of HIV RNA in the undiluted donor plasma whereas detection was inconsistent at the 1:16 and 1:24 dilution levels currently used in minipool screening of blood donations in the United States., Conclusions: Transmission of HIV from a blood donor to a platelet recipient and a red blood cell recipient occurred in the preseroconversion infectious window period. The viral load in the implicated donation was estimated to be less than 40 copies/mL of plasma. Current US minipool HIV NAT screening protocols may not be sufficiently sensitive to detect all infectious window-period donations. JAMA. 2000;284:210-214

Objective: To identify clinical and laboratory parameters at birth that are associated with the rapidly progressive form of human immunodeficiency virus type 1 (HIV-1) disease in children born to infected mothers., Design: Multicenter, prospective study of infants born to HIV-seropositive mothers., Setting: A total of 62 obstetric and pediatric centers in France., Participants: Of 1386 children born to HIV-1-seropositive mothers at least 18 months before the cutoff date, 267 were infected. Infection was defined as serological positivity at 18 months or death from HIV disease before the age., Main Outcome Measure: Category C events (including opportunistic infections, recurrent severe bacterial infections, cancers, specific encephalopathy, and wasting syndrome) in the new pediatric Centers for Disease Control and Prevention classification during the first year of life, according to clinical, immunological, and virological findings at birth., Results: The risk of category C manifestations at 12 months was significantly higher when an infected newborn had liver and/or spleen enlargement and/or adenopathies (38.1% vs 15.1%; relative risk [RR], 2.5; 95% confidence interval [CI], 1.4 to 6.0; P<.02) or a low proportion (<30%) of CD4+ cells at birth (45.5% vs 15.0%; RR, 3.0; 95% CI, 1.4 to 6.4; P<.005). Similarly, HIV-1 culture and/or polymerase chain reaction positivity during the first week of life was associated with a higher risk of the early, severe form of HIV infection (26.4% vs 9.3%; RR, 2.8; 95% CI, 1.3 to 6.1; P<.006). In case of positive antigenemia at birth, the risk was 50.0% vs 14.4% (RR, 3.5; 95% CI, 1.9 to 6.2; P<.001). These parameters, determined at birth, were strongly interrelated and could reflect active disease onset in utero in some cases of early, severe HIV-1 disease in childhood., Conclusions: These prognostic markers, particularly virological parameters, are of value in monitoring children infected by HIV and might serve as a basis for early therapeutic intervention.

Objective: To compare mother-to-child transmission of human immunodeficiency virus types 1 and 2 (HIV-1 and HIV-2, respectively) and to assess the impact of maternal HIV-1 and HIV-2 infections on child survival., Design: Prospective cohort study., Setting: Maternal and child health center in a lower socioeconomic class district of Abidjan, Ivory Coast., Participants: A total of 18,099 women delivering between 1990 and 1992 were tested for HIV-1 and HIV-2 antibodies. A cohort of 613 pregnant women and their infants was followed prospectively (138 women reactive to HIV-1, 132 reactive to HIV-2, 69 reactive to both viruses, and 274 HIV-seronegative)., Main Outcome Measures: Rates of perinatal transmission for HIV-1, HIV-2, and both viruses, determined from results of serological and polymerase chain reaction tests on children; survival of infants born to HIV-1-positive, HIV-2-positive, dually reactive, and HIV-seronegative women., Results: Of the 18,099 women tested, 9.4% were reactive to HIV-1 alone, 1.6% to HIV-2 alone, and 1.0% to both viruses. The rate of perinatal transmission of HIV-1 was 24.7% (95% confidence interval [CI], 15.8% to 33.7%), compared with 1.2% (95% CI, 0.0% to 3.5%) for HIV-2 (relative risk, 21.3; 95% CI, 2.9 to 154.3). Overall, 19.0% (95% CI, 9.0% to 29.0%) of infants of dually reactive women became infected; of the 11 children concerned, 10 were infected with HIV-1 and one with HIV-1 and HIV-2. Infants of HIV-seropositive mothers had a reduced survival; mortality rates were 15.1, 13.0, 6.5, and 3.4 deaths per 100 child-years, respectively, for children of HIV-1-positive, dually reactive, HIV-2-positive, and HIV-seronegative women., Conclusions: The rate of perinatal transmission of HIV-2 (1.2%) was much lower than the rate of perinatal transmission of HIV-1 (24.7%), and this was associated with more favorable survival for infants of HIV-2-infected mothers. Dually reactive women could transmit both viruses, although transmission usually involved HIV-1 only. Public health guidelines should incorporate advice that perinatal transmission of HIV-2 is rare.

Objective: To determine the prevalence and temporal expression of infectious human immunodeficiency virus type 1 (HIV-1) in the semen of HIV-1 seropositive men and to determine whether the detection of HIV-1 in semen is associated with disease stage, zidovudine treatment status, or other clinical factors., Design: A microculture technique was used to detect infectious HIV-1 in semen from a cohort of 95 seropositive men. In addition, semen cultures were performed monthly for at least 6 months for 14 of the men. Information was obtained by interview and extracted from medical records to identify clinical variables associated with HIV-1 in semen., Patients: Sixty HIV-1 seropositive homosexual men participating in clinical studies at the Fenway Community Health Center, Boston, Mass, and 35 HIV seropositive bisexual or heterosexual men participating in the California Partner Study of the University of California, San Francisco., Main Outcome Measures: Semen HIV-1 culture results, seminal leukocyte counts, Centers for Disease Control (CDC) disease stage, peripheral CD4+ cell counts, zidovudine therapy, HIV risk category., Results: In the cross-sectional study, HIV-1 was cultured from the semen of nine (9%) of 95 men. Factors associated with detection of HIV-1 in semen were peripheral CD4+ cell counts of 0.20 x 10(9)/L (200/microL) or less (adjusted odds ratio [OR], 23.33; 95% confidence interval [Cl], 2.89 to 175.63); symptomatic (CDC class IV) disease (adjusted OR, 6.56; 95% Cl, 1.02 to 66.76); and seminal leukocytosis (greater than 1 x 10(9) white blood cells per liter of semen) (adjusted OR, 7.02; 95% Cl, 1.28 to 39.29). Zidovudine therapy was associated with decreased detection of HIV-1 in semen (adjusted OR, 0.04; 95% Cl, 0.00 to 0.63). In the longitudinal study of 14 men who had neither peripheral CD4+ cells counts of 0.20 x 10(9)/L or less nor seminal leukocytosis, seminal HIV-1 was detected in at least one sample from six men (43%)., Conclusion: HIV-1 is more commonly found in semen from men with advanced HIV-1 infection and seminal leukocytosis but can also be cultured from semen of men with neither of these conditions. Zidovudine therapy may decrease the prevalence and/or titer of seminal HIV-1. However, all HIV-1-infected persons should continue to assume that they are potentially infectious through sexual contact.

Objective: To evaluate the effectiveness of human immunodeficiency virus (HIV) testing and posttest counseling in reducing subsequent high-risk behavior., Methods: The incidence of sexually transmitted diseases (STDs) in the Baltimore, Md, public STD clinic population after HIV testing and counseling was determined by chart review and was compared in two groups, 868 HIV-seropositive patients and 1104 HIV-seronegative patients, matched by age, sex, and month in which HIV test was conducted. Patients were observed for incident STDs at intervals of 6 through 23 months. Patients with incident STDs were classified hierarchically after being notified of the HIV test result and receiving posttest counseling., Results: Of HIV-seropositive patients, 615 (71%) returned for their test results and received posttest counseling; 694 HIV-seronegative patients (63%) returned. Of all those who returned for results and posttest counseling, 60 (9.7%) of 615 HIV-seropositive patients and 61 (8.8%) of 694 HIV-seronegative patients were diagnosed at least once with definite STD (syphilis, gonorrhea, or trichomoniasis) (P, not significant). Twenty-four HIV-seropositive patients (3.9%) and 71 HIV-seronegative patients (10.2%) returned with probable STD (nongonococcal urethritis or pelvic inflammatory disease) (P less than .001). Nine HIV-seropositive patients (1.5%) and 23 HIV-seronegative patients (3.3%) returned having had an STD-infected sexual partner (P less than .03). Age, sexual orientation, and drug use behavior did not predict return with STD., Conclusions: Both HIV-seropositive and HIV-seronegative patients showed high rates of repeat STDs after posttest counseling, an important public health challenge in creating effective high-risk behavior prevention strategies.

At least one third of patients enrolled in a methadone maintenance treatment program are willing to comply voluntarily with screening for and counseling about human immunodeficiency virus (HIV). A questionnaire about knowledge, attitudes, and behavior concerning acquired immunodeficiency syndrome was answered anonymously by 79% (46) of the clinical staff and 67% (868) of the enrolled patients. On their own initiative, 21% of the patients had already received voluntary anonymous HIV screening and brief counseling, seldom discussing the result with the staff. Approximately 90% of the staff and a majority of the patients (72%) thought a voluntary HIV screening program should be offered to all patients. Almost all staff (98%), but only 50% of the patients, felt the HIV test results should be known to physicians, nurses, and counselors at the clinic. Few staff members (15%) believed that patients had changed their sex behavior; more (48%) felt that needle sharing was reduced. Patients believed methadone patients in general had changed their sex behavior (49.2%) and reduced needle sharing (62%) to prevent becoming infected. Patients reported statistically significant reductions both in number of sex partners and in personal needle sharing during the past year.

We studied decisions to continue or terminate pregnancy among human immunodeficiency virus (HIV)-seropositive (+) and -seronegative (-) intravenous drug users informed of HIV antibody status before 24 weeks' gestation. Fourteen (50%) of 28 HIV+ vs 16 (44%) of 36 HIV- women chose to terminate their pregnancies. In retrospective interviews, HIV+ women were more likely to have perceived their risk of perinatal HIV transmission to be greater than or equal to 50% and, among those who terminated pregnancy, to cite this concern as an important factor in their decision. However, decisions to terminate pregnancy were predicted more readily by pregnancy-related variables such as prior elective abortion, a negative emotional reaction to pregnancy, and whether the pregnancy had been unplanned. Women who were HIV+ and chose to continue their pregnancies cited the desire for a child, religious beliefs, and family pressure as the most important factors in their decisions. Results indicate that while concerns about perinatal transmission of HIV may lead to decisions to terminate pregnancy in certain cases, there may be other determinants of pregnancy decisions in this population. Counseling of HIV-infected women must address not only perinatal transmission but also the sociocultural and behavioral context in which pregnancy decision making takes place.

We retrospectively studied the clinical use of human immunodeficiency virus (HIV) antibody serology at one 450-bed medical center and affiliated clinics from April 1985 through August 1986. No restrictions were placed on the use of HIV antibody serology during that time, although it was recommended that consent be obtained and risk-reduction information be provided. Testing was performed for 275 patients; results for 25 (9%) of these were positive. Nearly half (44%) of the patients had no recognized risk factor for HIV infection recorded in their charts. For an additional 44% of the patients, the test was medically indicated but consent and counseling were not documented. For only 10% of HIV antibody tests was there notation that consent was obtained and that risk-reduction information was provided. These results indicate that HIV antibody testing is often done without consent and that opportunities to provide risk-reduction counseling are being missed.

Unscreened blood transfusions continue to be one of the major modes of transmission of the human immunodeficiency virus (HIV) in developing countries, such as in Central Africa, where 5% to 18% of blood donors are HIV seropositive. We evaluated a rapid latex agglutination assay using a novel recombinant envelope polypeptide of HIV for the detection of HIV antibodies among 2820 blood donors and clinical patients from diverse geographic regions, including on-site testing in Central Africa of 1600 blood donors. Overall, 29.2% of the serum samples were positive by Western blot assay. On a single determination, the latex agglutination slide test was found to be highly sensitive and specific compared with Western blot results in these populations with a relatively high prevalence of infection. Use of this assay will allow the immediate implementation of serologic screening for HIV in developing areas of the world, where standard screening procedures are impractical or not available, and in many other clinical settings, such as sexually transmitted diseases clinics and hospitals, where testing and counseling could be promptly implemented.

To determine the effects of human immunodeficiency virus (HIV) infection on pregnancy outcomes, we prospectively studied female intravenous drug users in a methadone program in New York City. Of 191 women with HIV status known prior to pregnancy, 17 (24%) of 70 seropositives and 26 (22%) of 121 seronegatives became pregnant during 28 months of follow-up. Including 54 additional women first tested for HIV antibody after becoming pregnant, 125 pregnancies were studied in 97 women (39 seropositive, 58 seronegative). None of the seropositive pregnant women had advanced HIV-related disease at entry, and only one developed symptomatic disease (oral candidiasis) during pregnancy. No differences were observed between groups in the frequency of spontaneous or elective abortion, ectopic pregnancy, preterm delivery, stillbirth, or low-birth-weight births. Among women giving birth to live infants, seropositives were more likely than seronegatives to be hospitalized for bacterial pneumonia during pregnancy and had an increased tendency for breech presentation, although these events were infrequent. There were otherwise no differences between groups in the occurrence of antenatal, intrapartum, or neonatal complications. Results suggest that asymptomatic HIV infection is not associated with a decreased pregnancy rate or an increased risk of adverse pregnancy outcomes in intravenous drug users, and that an acceleration in HIV-disease status during pregnancy is uncommon.

The acquired immunodeficiency syndrome was first recognized as a clinical entity in the United States in the early 1980s; however, the issue of when human immunodeficiency virus, the causative agent of the acquired immunodeficiency syndrome, was introduced into at-risk populations in the United States is unresolved. Previously, we reported the case study of a 15-year-old black male who was admitted to St Louis City Hospital in 1968 for extensive lymphedema of the genitalia and lower extremities. Chlamydial organisms were widely disseminated and isolated from numerous body fluids and organs. Over a 16-month clinical course his condition progressively deteriorated, and at autopsy there was widespread Kaposi's sarcoma of the aggressive, disseminated type. Recently performed Western blot and antigen capture assays on serum and autopsy tissue specimens frozen since 1969 have disclosed that this sexually active teenager was infected with a virus closely related or identical to human immunodeficiency virus type 1. The clinical and immunologic findings together suggest that an immunosuppressive retrovirus existed in the United States before the late 1970s.

A questionnaire that asked about policies concerning the use of human immunodeficiency virus (HIV) antibody tests was sent in January 1987 to the 200 hospitals in the United States that conduct infectious disease (ID) fellowship training (US ID hospitals) and to all 171 short-term-care Minnesota hospitals. Information was received from 189 of the US ID hospitals (94.5%) and from 160 (94%) of the Minnesota hospitals. Only 49% of the US ID hospitals and 37% of the Minnesota hospitals had an HIV antibody test-ordering policy; 47% of the US ID hospitals and 39% of the Minnesota hospitals had a specific educational program for physicians about the HIV antibody test; and 62% of the US ID hospitals and 41% of the Minnesota hospitals had an HIV autopsy policy. Marked variety existed in approaches to handling test results, obtaining patient consent, and providing risk-reduction information among the hospitals surveyed. These data suggest the need for a consensus on optimal use of HIV antibody testing at hospitals.

During the first 6 months of legislatively mandated premarital testing for human immunodeficiency virus in Illinois, 8 of 70,846 applicants for marriage licenses were found to be seropositive, yielding a seroprevalence of 0.011%. The total cost of the testing program for 6 months is estimated at $2.5 million or $312,000 per seropositive individual identified. Half of the reported seropositive individuals reported a history of risk behavior. During the same period, the number of marriage licenses issued in Illinois decreased by 22.5%, while the number of licenses issued to Illinois residents in surrounding states increased significantly. We conclude that mandatory premarital testing is not a cost-effective method for the control of human immunodeficiency virus infection.