HIV infection among children and adolescents in Burundi, Cameroon, and the Democratic Republic of Congo.

Evidence demonstrates a substantial HIV epidemic among children and adolescents in countries with long-standing generalized HIV epidemics, where availability of prevention of mother-to-child transmission services has historically been limited. The objective of this research was to explore factors associated with antiretroviral therapy (ART) initiation and morbidity among HIV-infected surviving children 2-17 years of age attending HIV programs in Central Africa. Programmatic data from 404 children attending HIV programs in Burundi, Cameroon, and the Democratic Republic of Congo (DRC) were included in our evaluation. Children were followed prospectively from 2008 to 2011 according to each clinic's standard of care. Diagnosis at a reference hospital was significantly associated with not having initiated ART (adjusted odds ratio, AOR = 0.40; 95% confidence interval, CI, 0.24-0.67). Being seen at a clinic in Cameroon (AOR = 0.45; 95%CI = 0.24-0.85) and being in school were associated with decreased risk (AOR = 0.55; 95%CI = 0.31-0.96). Being ART-naïve (AOR = 1.88; 95%CI = 1.20-2.94) and being diagnosed at a reference hospital (AOR = 2.39; 95%CI = 1.29-4.41) or other testing facility (AOR = 2.86; 95%CI = 1.32-6.18) were associated with increased risk of having a morbid event at the initial visit. In longitudinal analysis of incident morbidity, we found a decreased risk associated with attending clinics in Cameroon (adjusted hazard ratio, AHR = 0.23; 95%CI = 0.11-0.46) and the DRC (AHR = 0.46; 95%CI = 0.29-0.74), and an increased risk associated with being ART-naïve (AHR = 1.83; 95%CI = 1.12-2.97). We found a high burden of HIV-related health problems among children receiving care in this setting. Children face significant barriers to accessing HIV services, and the HIV epidemic among surviving children in the Central African region has not been adequately evaluated nor addressed.

Promoting Partner Testing and Couples Testing through Secondary Distribution of HIV Self-Tests: A Randomized Clinical Trial.

BACKGROUND: Achieving higher rates of partner HIV testing and couples testing among pregnant and postpartum women in sub-Saharan Africa is essential for the success of combination HIV prevention, including the prevention of mother-to-child transmission. We aimed to determine whether providing multiple HIV self-tests to pregnant and postpartum women for secondary distribution is more effective at promoting partner testing and couples testing than conventional strategies based on invitations to clinic-based testing. METHODS AND FINDINGS: We conducted a randomized trial in Kisumu, Kenya, between June 11, 2015, and January 15, 2016. Six hundred antenatal and postpartum women aged 18-39 y were randomized to an HIV self-testing (HIVST) group or a comparison group. Participants in the HIVST group were given two oral-fluid-based HIV test kits, instructed on how to use them, and encouraged to distribute a test kit to their male partner or use both kits for testing as a couple. Participants in the comparison group were given an invitation card for clinic-based HIV testing and encouraged to distribute the card to their male partner, a routine practice in many health clinics. The primary outcome was partner testing within 3 mo of enrollment. Among 570 participants analyzed, partner HIV testing was more likely in the HIVST group (90.8%, 258/284) than the comparison group (51.7%, 148/286; difference = 39.1%, 95% CI 32.4% to 45.8%, p < 0.001). Couples testing was also more likely in the HIVST group than the comparison group (75.4% versus 33.2%, difference = 42.1%, 95% CI 34.7% to 49.6%, p < 0.001). No participants reported intimate partner violence due to HIV testing. This study was limited by self-reported outcomes, a common limitation in many studies involving HIVST due to the private manner in which self-tests are meant to be used. CONCLUSIONS: Provision of multiple HIV self-tests to women seeking antenatal and postpartum care was successful in promoting partner testing and couples testing. This approach warrants further consideration as countries develop HIVST policies and seek new ways to increase awareness of HIV status among men and promote couples testing. TRIAL REGISTRATION: ClinicalTrials.gov NCT02386215.

Mycoplasma genitalium is associated with increased genital HIV type 1 RNA in Zimbabwean women.

BACKGROUND: Mycoplasma genitalium is a common sexually transmitted infection associated with human immunodeficiency virus (HIV) infection. Some studies suggest that M. genitalium may increase the risk of HIV acquisition. However, results have been inconsistent, and this association has never been examined longitudinally. METHODS: Stored endocervical samples from a longitudinal cohort study of 131 Zimbabwean women in whom HIV-1 seroconversion recently occurred were tested for detection and quantity of M. genitalium using polymerase chain reaction analysis. The associations between M. genitalium and the detection and quantity of genital HIV type 1 (HIV-1) RNA, the detection and quantity of plasma HIV-1 RNA, and the CD4(+) T-cell count was analyzed using mixed-effects regression analysis. RESULTS: M. genitalium was detected in 10.5% of stored specimens (44 of 420), and infection persisted for up to 300 days. M. genitalium was independently associated with detection of genital HIV-1 RNA (adjusted odds ratio, 2.67; 95% confidence interval, .99-7.20), after adjustment for plasma viral load, viral set point, CD4(+) T-cell count, herpes simplex virus type 2 detection, and gonorrhea. There was no evidence of an association between M. genitalium detection or quantity and either plasma HIV-1 RNA load or CD4(+) T-cell count. CONCLUSIONS: The growing evidence for an association between M. genitalium and HIV genital shedding and the high prevalence and persistence of M. genitalium in this population suggest that further research into this association is important. Consideration of the cost-effectiveness of M. genitalium screening interventions may be warranted.

Assessment of the Potential Impact and Cost-effectiveness of Self-Testing for HIV in Low-Income Countries.

BACKGROUND: Studies have demonstrated that self-testing for human immunodeficiency virus (HIV) is highly acceptable among individuals and could allow cost savings, compared with provider-delivered HIV testing and counseling (PHTC), although the longer-term population-level effects are uncertain. We evaluated the cost-effectiveness of introducing self-testing in 2015 over a 20-year time frame in a country such as Zimbabwe. METHODS: The HIV synthesis model was used. Two scenarios were considered. In the reference scenario, self-testing is not available, and the rate of first-time and repeat PHTC is assumed to increase from 2015 onward, in line with past trends. In the intervention scenario, self-testing is introduced at a unit cost of $3. RESULTS: We predict that the introduction of self-testing would lead to modest savings in healthcare costs of $75 million, while averting around 7000 disability-adjusted life-years over 20 years. Findings were robust to most variations in assumptions; however, higher cost of self-testing, lower linkage to care for people whose diagnosis is a consequence of a positive self-test result, and lower threshold for antiretroviral therapy eligibility criteria could lead to situations in which self-testing is not cost-effective. CONCLUSIONS: This analysis suggests that introducing self-testing offers some health benefits and may well save costs.

Modelling the potential population impact and cost-effectiveness of self-testing for HIV: evaluation of data requirements.

HIV testing uptake has increased dramatically in recent years in resource limited settings. Nevertheless, over 50% of the people living with HIV are still unaware of their status. HIV self-testing (HIVST) is a potential new approach to facilitate further uptake of testing which requires consideration, taking into account economic factors. Mathematical models and associated economic analysis can provide useful assistance in decision-making processes, offering insight, in this case, into the potential long-term impact at a population level and the price-point at which free or subsidized HIVST would be cost-effective in a given setting. However, models are based on assumptions, and if the required data are sparse or limited, this uncertainty will be reflected in the results from mathematical models. The aim of this paper is to describe the issues encountered in modeling the cost-effectiveness of introducing HIVST, to indicate the evidence needed to support various modeling assumptions, and thus which data on HIVST would be most beneficial to collect.

A review of self-testing for HIV: research and policy priorities in a new era of HIV prevention.

Inadequate uptake of testing for human immunodeficiency virus (HIV) remains a primary bottleneck toward universal access to treatment and care, and is an obstacle to realizing the potential of new interventions for preventing HIV infection, including treatment for prevention and preexposure prophylaxis. HIV self-testing offers an approach to scaling up testing that could be high impact, low cost, confidential, and empowering for users. Although HIV self-testing was first considered >20 years ago, it has not been widely implemented. We conducted a review of policy and research on HIV self-testing, which indicates that policy is shifting toward a more flexible approach with less emphasis on pretest counseling and that HIV self-testing has been adopted in a number of settings. Empirical research on self-testing is limited, resulting in a lack of an evidence base upon which to base policy recommendations. Relevant research and investment in programs are urgently needed to enable consideration of developing formalized self-testing programs.

The sexual behaviour of adolescents in sub-Saharan Africa: patterns and trends from national surveys.

OBJECTIVES: To describe the sexual and reproductive behaviour of adolescents in sub-Saharan Africa, particularly 15- to 19-year-olds. METHODS: Using DHS/AIS data (2000-2010), nine indicators of adolescent behaviour and one of adult attitudes towards condom education for adolescents were described for 24 countries. Indicators were disaggregated by gender, urban/rural residency and educational status, and time trends were described. RESULTS: Up to 25% of 15- to 19-year-olds reported sex before age 15; this proportion shrank over time in many countries. In most countries, ≥5% of females reported marriage before age 15, and >20% had commenced childbearing. Early sexual debut and childbearing were more common among the least educated and/or rural females. Reporting of multiple sexual partnerships was more common among males than among females, but decreases over time were more common among males. Urban males and females, and females with higher education, were more likely to report multiple partnerships. Urban youth and those with higher education also reported more condom use. Adult support for condom education for 12- to 14-year-olds has increased over time to 60-65%. CONCLUSIONS: Many 15- to 19-year-olds are at risk of HIV/STIs and unplanned pregnancies because of multiple partnerships and insufficient condom and other contraceptive use. In many countries, trends are moving in a favourable direction. To better inform prevention programmes in this important area, we recommend routine collection of sexual and reproductive behaviour data for adolescents aged <15 years, expanding the data collected for 15- to 19-year-olds to include detailed information on sexual behaviour within partnerships, and disaggregating data according to sociodemographic variables.

Preference between precoital and daily use of Duet® and BufferGel in Zimbabwe.

Duet® is a microbicide-delivery system and cervical barrier for use daily or precoitally. We conducted a crossover study among 80 Zimbabwean women to explore factors associated with use-regimen preference. Women were assigned in random order to 14 days of precoital and 14 days of daily Duet and BufferGel use. About 51 % of women preferred precoital use, 39 % preferred daily use, and 10 % liked both equally. Overall product adherence during sex was similar for both use-regimens. In multivariable analysis, diaphragm experience was associated with preference for precoital use (AOR 2.80, 95 % CI 1.01-7.76). Reasons for preferring precoital use included use only when needed, cleanliness, and discomfort with daily use. Daily use preference included convenience, discreetness, and being prepared for "sex-on-demand." Different personal and life circumstances may result in varying use-regimen preferences. Methods that can accommodate both coitally-related and daily use may be advantageous by providing more choice to users.

The uptake and accuracy of oral kits for HIV self-testing in high HIV prevalence setting: a cross-sectional feasibility study in Blantyre, Malawi.

BACKGROUND: Although HIV testing and counseling (HTC) uptake has increased dramatically in Africa, facility-based services are unlikely to ever meet ongoing need to the full. A major constraint in scaling up community and home-based HTC services is the unacceptability of receiving HTC from a provider known personally to prospective clients. We investigated the potential of supervised oral HIV self-testing from this perspective. METHODS AND FINDINGS: Adult members of 60 households and 72 members of community peer groups in urban Blantyre, Malawi, were selected using population-weighted random cluster sampling. Participants were offered self-testing plus confirmatory HTC (parallel testing with two rapid finger-prick blood tests), standard HTC alone, or no testing. 283 (95.6%) of 298 selected adults participated, including 136 (48.0%) men. 175 (61.8%) had previously tested (19 known HIV positive), although only 64 (21.5%) within the last year. HIV prevalence was 18.5%. Among 260 (91.9%) who opted to self-test after brief demonstration and illustrated instructions, accuracy was 99.2% (two false negatives). Although 98.5% rated the test "not hard at all to do," 10.0% made minor procedural errors, and 10.0% required extra help. Most participants indicated willingness to accept self-test kits, but not HTC, from a neighbor (acceptability 94.5% versus 46.8%, p = 0.001). CONCLUSIONS: Oral supervised self-testing was highly acceptable and accurate, although minor errors and need for supervisory support were common. This novel option has potential for high uptake at local community level if it can be supervised and safely linked to counseling and care.

Epidemiological synergy of Trichomonas vaginalis and HIV in Zimbabwean and South African women.

BACKGROUND: Trichomonas vaginalis (T. vaginalis) is the most common nonviral sexually transmitted infection in the world. Despite the coexisting global epidemics of T. vaginalis and HIV, little attention has focused on the emerging evidence that T. vaginalis increases susceptibility to, and potentially transmission of, HIV. METHODS: We evaluated T. vaginalis infection in the context of a multisite, randomized controlled trial amongst women in South Africa and Zimbabwe, to determine first, if risk of HIV acquisition was increased among women recently infected with T. vaginalis, and second, if risk of T. vaginalis acquisition was increased among women infected with HIV. RESULTS: After controlling for potential confounders, participants infected with T. vaginalis were more likely to test positive for HIV at their following visit, compared to participants uninfected with T. vaginalis (adjusted hazard ratio = 2.05; 95% CI, 1.05-4.02). Similarly, HIV-positive participants were twice as likely to have acquired T. vaginalis infection at the following visit, compared to HIV-negative participants (adjusted hazard ratio = 2.12; 95% CI, 1.35-3.32). CONCLUSIONS: We found an increased risk of both HIV acquisition associated with T. vaginalis infection and risk of T. vaginalis acquisition associated with HIV infection. This bidirectional relationship represents a potentially important factor in sustaining the HIV epidemic in populations where T. vaginalis is endemic.

A qualitative study of secondary distribution of HIV self-test kits by female sex workers in Kenya.

Promoting awareness of serostatus and frequent HIV testing is especially important among high risk populations such as female sex workers (FSW) and their sexual partners. HIV self-testing is an approach that is gaining ground in sub-Saharan Africa as a strategy to increase knowledge of HIV status and promote safer sexual decisions. However, little is known about self-test distribution strategies that are optimal for increasing testing access among hard-to-reach and high risk individuals. We conducted a qualitative study with 18 FSW who participated in a larger study that provided them with five oral fluid-based self-tests, training on how to use the tests, and encouragement to offer the self-tests to their sexual partners using their discretion. Women demonstrated agency in the strategies they used to introduce self-tests to their partners and to avoid conflict with partners. They carefully considered with whom to share self-tests, often assessing the possibility for negative reactions from partners as part of their decision making process. When women faced negative reactions from partners, they drew on strategies they had used before to avoid conflict and physical harm from partners, such as not responding to angry partners and forgoing payment to leave angry partners quickly. Some women also used self-tests to make more informed sexual decisions with their partners.

Effect of non-monetary incentives on uptake of couples' counselling and testing among clients attending mobile HIV services in rural Zimbabwe: a cluster-randomised trial.

BACKGROUND: Couples' HIV testing and counselling (CHTC) is associated with greater engagement with HIV prevention and care than individual testing and is cost-effective, but uptake remains suboptimal. Initiating discussion of CHTC might result in distrust between partners. Offering incentives for CHTC could change the focus of the pre-test discussion. We aimed to determine the impact of incentives for CHTC on uptake of couples testing and HIV case diagnosis in rural Zimbabwe. METHODS: In this cluster-randomised trial, 68 rural communities (the clusters) in four districts receiving mobile HIV testing services were randomly assigned (1:1) to incentives for CHTC or not. Allocation was not masked to participants and researchers. Randomisation was stratified by district and proximity to a health facility. Within each stratum random permutation was done to allocate clusters to the study groups. In intervention communities, residents were informed that couples who tested together could select one of three grocery items worth US$1·50. Standard mobilisation for testing was done in comparison communities. The primary outcome was the proportion of individuals testing with a partner. Analysis was by intention to treat. 3 months after CHTC, couple-testers from four communities per group individually completed a telephone survey to evaluate any social harms resulting from incentives or CHTC. The effect of incentives on CHTC was estimated using logistic regression with random effects adjusting for clustering. The trial was registered with the Pan African Clinical Trial Registry, number PACTR201606001630356. FINDINGS: From May 26, 2015, to Jan 29, 2016, of 24 679 participants counselled with data recorded, 14 099 (57·1%) were in the intervention group and 10 580 (42·9%) in the comparison group. 7852 (55·7%) testers in the intervention group versus 1062 (10·0%) in the comparison group tested with a partner (adjusted odds ratio 13·5 [95% CI 10·5-17·4]). Among 427 (83·7%) of 510 eligible participants who completed the telephone survey, 11 (2·6%) reported that they were pressured or themselves pressured their partner to test together; none regretted couples' testing. Relationship unrest was reported by eight individuals (1·9%), although none attributed this to incentives. INTERPRETATION: Small non-monetary incentives, which are potentially scalable, were associated with significantly increased CHTC and HIV case diagnosis. Incentives did not increase social harms beyond the few typically encountered with CHTC without incentives. The intervention could help achieve UNAIDS 90-90-90 targets. FUNDING: The study was funded by the UK Department for International Development, Irish AID, and Swedish SIDA, through Population Services International Zimbabwe under the Integrated Support Program.

The HIV Care Cascade Among Female Sex Workers in Zimbabwe: Results of a Population-Based Survey From the Sisters Antiretroviral Therapy Programme for Prevention of HIV, an Integrated Response (SAPPH-IRe) Trial.

INTRODUCTION: Female sex workers (FSW) in sub-Saharan Africa have a higher prevalence of HIV than other women of reproductive age. Social, legal, and structural barriers influence their access to care. Little is known about the HIV diagnosis and care cascade in most countries in Southern Africa. We aimed to describe the HIV diagnosis and care cascade among FSW in Zimbabwe. METHODS: We conducted cross-sectional respondent driven sampling (RDS) surveys of FSW in 14 sites across Zimbabwe as the baseline for a cluster-randomised controlled trial investigating a combination HIV prevention and care package. We administered a questionnaire, tested women for HIV and measured viral load. We report the mean, minimum, and maximum respondent-driven sampling-2 weighted site values. RESULTS: The survey included 2722 women, approximately 200 per site. The mean HIV prevalence was 57.5% (42.8-79.2 site minimum and maximum). Of HIV-positive women, 64.0% (51.6-73.7) were aware of their status, 67.7% (53.4-84.1) of these reported taking antiretroviral therapy, and 77.8% (64.4-90.8) of these had a suppressed HIV viral load (<1000 copies/mL). Among all HIV-positive women, 49.5% had a viral load < 1000 copies/mL. CONCLUSIONS: Although most HIV-positive women aware of their status are accessing antiretroviral therapy, 36.0% of HIV-positive women are unaware of their status and 29.3% of all FSW have an unsuppressed HIV viral load. Investigation and investment into models of testing, treatment, and care are necessary to reach UNAIDS targets for HIV elimination.

Promoting male partner HIV testing and safer sexual decision making through secondary distribution of self-tests by HIV-negative female sex workers and women receiving antenatal and post-partum care in Kenya: a cohort study.

BACKGROUND: Increased uptake of HIV testing by men in sub-Saharan Africa is essential for the success of combination prevention. Self-testing is an emerging approach with high acceptability, but little evidence exists on the best strategies for test distribution. We assessed an approach of providing multiple self-tests to women at high risk of HIV acquisition to promote partner HIV testing and to facilitate safer sexual decision making. METHODS: In this cohort study, HIV-negative women aged 18-39 years were recruited at two sites in Kisumu, Kenya: a health facility with antenatal and post-partum clinics and a drop-in centre for female sex workers. Participants gave informed consent and were instructed on use of oral fluid based rapid HIV tests. Participants enrolled at the health facility received three self-tests and those at the drop-in centre received five self-tests. Structured interviews were conducted with participants at enrolment and over 3 months to determine how self-tests were used. Outcomes included the number of self-tests distributed by participants, the proportion of participants whose sexual partners used a self-test, couples testing, and sexual behaviour after self-testing. FINDINGS: Between Jan 14, 2015, and March 13, 2015, 280 participants were enrolled (61 in antenatal care, 117 in post-partum care, and 102 female sex workers); follow-up interviews were completed for 265 (96%). Most participants with primary sexual partners distributed self-tests to partners: 53 (91%) of 58 participants in antenatal care, 91 (86%) of 106 in post-partum care, and 64 (75%) of 85 female sex workers. 82 (81%) of 101 female sex workers distributed more than one self-test to commercial sex clients. Among self-tests distributed to and used by primary sexual partners of participants, couples testing occurred in 27 (51%) of 53 in antenatal care, 62 (68%) of 91 from post-partum care, and 53 (83%) of 64 female sex workers. Among tests received by primary and non-primary sexual partners, two (4%) of 53 tests from participants in antenatal care, two (2%) of 91 in post-partum care, and 41 (14%) of 298 from female sex workers had positive results. Participants reported sexual intercourse with 235 (62%) of 380 sexual partners who tested HIV-negative, compared with eight (18%) of 45 who tested HIV-positive (p<0·0001); condoms were used in all eight intercourse events after positive results compared with 104 (44%) after of negative results (p<0·0018). Four participants reported intimate partner violence as a result of self-test distribution: two in the post-partum care group and two female sex workers. No other adverse events were reported. INTERPRETATION: Provision of multiple HIV self-tests to women at high risk of HIV infection was successful in promoting HIV testing among their sexual partners and in facilitating safer sexual decisions. This novel strategy warrants further consideration as countries develop self-testing policies and programmes. FUNDING: Bill & Melinda Gates Foundation.

Implementation and Operational Research: Cohort Analysis of Program Data to Estimate HIV Incidence and Uptake of HIV-Related Services Among Female Sex Workers in Zimbabwe, 2009-2014.

BACKGROUND: HIV epidemiology and intervention uptake among female sex workers (FSW) in sub-Saharan Africa remain poorly understood. Data from outreach programs are a neglected resource. METHODS: Analysis of data from FSW consultations with Zimbabwe's National Sex Work program, 2009-2014. At each visit, data were collected on sociodemographic characteristics, HIV testing history, HIV tests conducted by the program and antiretroviral (ARV) history. Characteristics at first visit and longitudinal data on program engagement, repeat HIV testing, and HIV seroconversion were analyzed using a cohort approach. RESULTS: Data were available for 13,360 women, 31,389 visits, 14,579 reported HIV tests, 2750 tests undertaken by the program, and 2387 reported ARV treatment initiations. At first visit, 72% of FSW had tested for HIV; 50% of these reported being HIV positive. Among HIV-positive women, 41% reported being on ARV. 56% of FSW attended the program only once. FSW who had not previously had an HIV-positive test had been tested within the last 6 months 27% of the time during follow-up. After testing HIV positive, women started on ARV at a rate of 23/100 person years of follow-up. Among those with 2 or more HIV tests, the HIV seroconversion rate was 9.8/100 person years of follow-up (95% confidence interval: 7.1 to 15.9). CONCLUSIONS: Individual-level outreach program data can be used to estimate HIV incidence and intervention uptake among FSW in Zimbabwe. Current data suggest very high HIV prevalence and incidence among this group and help identify areas for program improvement. Further methodological validation is required.

Finger Prick Dried Blood Spots for HIV Viral Load Measurement in Field Conditions in Zimbabwe.

BACKGROUND: In the context of a community-randomized trial of antiretrovirals for HIV prevention and treatment among sex workers in Zimbabwe (the SAPPH-IRe trial), we will measure the proportion of women with HIV viral load (VL) above 1000 copies/mL ("VL>1000") as our primary endpoint. We sought to characterize VL assay performance by comparing results from finger prick dried blood spots (DBS) collected in the field with plasma samples, to determine whether finger prick DBS is an acceptable sample for VL quantification in the setting. METHODS: We collected whole blood from a finger prick onto filter paper and plasma samples using venipuncture from women in two communities. VL quantification was run on samples in parallel using NucliSENS EasyQ HIV-1 v2.0. Our trial outcome is the proportion of women with VL>1000, consistent with WHO guidelines relating to regimen switching. We therefore focused on this cut-off level for assessing sensitivity and specificity. Results were log transformed and the mean difference and standard deviation calculated, and correlation between VL quantification across sample types was evaluated. RESULTS: A total of 149 HIV-positive women provided DBS and plasma samples; 56 (63%) reported being on antiretroviral therapy. VL ranged from undetectable-6.08 log10 using DBS and undetectable-6.40 log10 using plasma. The mean difference in VL (plasma-DBS) was 0.077 log10 (95%CI = 0.025-0.18 log10; standard deviation = 0.63 log10,). 78 (52%) DBS and 87 (58%) plasma samples had a VL>1000. Based on plasma 'gold-standard', DBS sensitivity for detection of VL>1000 was 87.4%, and specificity was 96.8%. CONCLUSION: There was generally good agreement between DBS and plasma VL for detection of VL>1000. Overall, finger prick DBS appeared to be an acceptable sample for classifying VL as above or below 1000 copies/mL using the NucliSENS assay.

Effective approaches for programming to reduce adolescent vulnerability to HIV infection, HIV risk, and HIV-related morbidity and mortality: a systematic review of systematic reviews.

BACKGROUND: In 2012, an estimated 2.1 million adolescents were living with HIV. Though there are effective interventions to prevent and treat HIV infection, adolescents face specific barriers in accessing them. As a result, new infections and poor outcomes among HIV-infected adolescents are common. HIV programming for adolescents should focus on interventions of proven effectiveness and address underlying factors driving incidence and lack of effective treatment and care in this age group. METHODS: We conducted a systematic review of systematic reviews to summarize the global data on effectiveness of 20 intervention types, to identify characteristics of effective interventions, and to explore evidence of how adolescents can access interventions with proven effectiveness. Interventions were in 2 broad categories: those designed primarily for adults and those designed specifically for adolescents. Where available, we evaluated the evidence of impact on the key outcomes: HIV risk, HIV transmission, and HIV morbidity and mortality. RESULTS: Among the interventions designed for adolescents, there was high-quality evidence that in-school interventions and some interventions in geographically defined communities can positively impact important HIV-related outcomes, such as self-reported sexual risk behaviors. Interventions designed primarily for adults that had high-quality, consistent biological evidence of efficacy included voluntary medical male circumcision (VMMC), antiretrovirals for the prevention of mother-to-child transmission, HIV testing and counseling, HIV treatment, condom use, and provision of sterile injecting equipment to people who inject drugs. There was also an evidence of potential efficacy for oral preexposure prophylaxis and behavior change interventions among certain populations. There was a dearth of systematic review data on how best to enable adolescents to access the intervention types identified as having proven effectiveness among adults. CONCLUSIONS: This series of reviews allowed us to rigorously and systematically review a large number of intervention types at once using a standard, transparent methodology. Eight key interventions showed clear evidence of effectiveness, with evidence of potential efficacy for some additional interventions among certain populations. DISCUSSION: These priority interventions with proven effectiveness should be included in all HIV prevention programming for adolescents. There is a pressing need for more rigorous research on how best to enable adolescents to access these effective interventions.

Provider counseling to young women seeking family planning services.

CONTEXT: Contraceptive nonuse and misuse contribute to rates of unintended pregnancy and STDs among young women in the United States. Clinical providers assume an important role in guiding youths' contraceptive method choices. METHODS: Sixty-seven women aged 16-21 were recruited as part of a cohort study, conducted in 2009-2012, that examined provider-patient interactions during family planning visits at six San Francisco clinics. Interactions between patients and providers were audio-recorded. Participants completed questionnaires about method preference immediately before seeing the provider; they reported on method choice immediately after the visit and by telephone three and six months later. Transcripts were analyzed to examine providers' strategies for guiding decision making and addressing youths' contraceptive concerns. Missed opportunities for promoting young women's reproductive health were identified. RESULTS: Twenty-one percent of young women who did not report desiring a hormonal or long-acting reversible method (IUD or implant) before seeing their provider chose one after counseling. Use of a hormonal or long-acting reversible contraceptive method at follow-up was more common among women who had received interactive counseling by providers who guided them to consider contextual influences than among those who had not received such counseling. Attention to relationship characteristics, sexual behavior patterns and STD risk was largely absent from contraceptive counseling. CONCLUSION: High-quality strategies used by providers to guide contraceptive decision making were tailored to adolescents' developmental and environmental needs. Several areas of counseling require increased attention and seem vital to providing comprehensive reproductive health care to adolescents.

Development of a rotor-gene real-time PCR assay for the detection and quantification of Mycoplasma genitalium.

We developed and validated a real-time quantitative polymerase chain reaction (qPCR) assay to determine Mycoplasma genitalium bacterial load in endocervical swabs, based on amplification of the pdhD gene which encodes dihydrolipoamide dehydrogenase, using the Rotor-Gene platform. We first determined the qPCR assay sensitivity, limit of detection, reproducibility and specificity, and then determined the ability of the qPCR assay to quantify M. genitalium in stored endocervical specimens collected from Zimbabwean women participating in clinical research undertaken between 1999 and 2007. The qPCR assay had a detection limit of 300 genome copies/mL and demonstrated low intra- and inter-assay variability. The assay was specific for M. genitalium DNA and did not amplify the DNA from other mycoplasma and ureaplasma species. We quantified M. genitalium in 119 of 1600 endocervical swabs that tested positive for M. genitalium using the commercial Sacace M. genitalium real-time PCR, as well as 156 randomly selected swabs that were negative for M. genitalium by the same assay. The M. genitalium loads ranged between <300 and 3,240,000 copies/mL. Overall, the qPCR assay demonstrated good range of detection, reproducibility and specificity and can be used for both qualitative and quantitative analyses of M. genitalium in endocervical specimens and potentially other genital specimens.

The association between Mycoplasma genitalium and HIV-1 acquisition in African women.

OBJECTIVE: Mycoplasma genitalium is an emerging sexually transmitted infection (STI) and has been associated with reproductive tract infections and HIV in cross-sectional studies. In this longitudinal study, we assess whether M. genitalium is associated with risk of acquiring HIV-1 infection. DESIGN: Nested case-control study within a large prospective study in Zimbabwe and Uganda METHODS: A total of 190 women who seroconverted to HIV-1 during follow-up (cases) were matched with up to two HIV-negative controls. Mycoplasma genitalium testing was performed by PCR-ELISA, using archived cervical samples from the HIV-1 detection visit and the last HIV-negative visit for cases, and equivalent visits in follow-up time for controls. Risk factors for HIV-1 acquisition were analyzed using conditional logistic regression, with M. genitalium as the primary exposure. RESULTS: Mycoplasma genitalium was a common infection in these populations (14.8 and 6.5% prevalence among cases and controls, respectively, at the visit prior to HIV-1 detection), and more prevalent than other nonviral STIs. We found a greater than two-fold independent increased risk of HIV-1 acquisition among women infected with M. genitalium at the visit prior to HIV-1 acquisition [adjusted odds ratio (AOR) = 2.42; 95% confidence interval (CI) 1.01-5.80), and at time of HIV-1 acquisition (AOR = 2.18; 95% CI 0.98-4.85). An estimated 8.7% (95% CI 0.1-12.2%) of incident HIV-1 infections were attributable to M. genitalium. CONCLUSION: This is the first longitudinal study to assess the relationship between M. genitalium and HIV-1 acquisition. If findings from this research are confirmed, M. genitalium screening and treatment among women at high risk for HIV-1 infection may be warranted as part of an HIV-1 prevention strategy.