Routine Opt-Out HIV Testing Strategies in a Female Jail Setting: A Prospective Controlled Trial

Background

Ten million Americans enter jails annually. The objective was to evaluate new CDC guidelines for routine opt-out HIV testing and examine the optimal time to implement routine opt-out HIV testing among newly incarcerated jail detainees.

Methods

This prospective, controlled trial of routine opt-out HIV testing was conducted among 323 newly incarcerated female inmates in Connecticut''s only women''s jail. 323 sequential entrants to the women''s jail over a five week period in August and September 2007 were assigned to be offered routine opt-out HIV testing at one of three points after incarceration: immediate (same day, n = 108), early (next day, n = 108), or delayed (7 days, n = 107). The primary outcome was the proportion of women in each group consenting to testing.

Results

Routine opt-out HIV testing was significantly highest (73%) among the early testing group compared to 55% for immediate and 50% for 7 days post-entry groups. Other factors significantly (p = 0.01) associated with being HIV tested were younger age and low likelihood of early release from jail based on bond value or type of charge for which women were arrested.

Conclusions

In this correctional facility, routine opt-out HIV testing in a jail setting was feasible, with highest rates of testing if performed the day after incarceration. Lower testing rates were seen with immediate testing, where there is a high prevalence of inability or unwillingness to test, and with delayed testing, where attrition from jail increases with each passing day.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00624247","term_id":"NCT00624247"}}NCT00624247     

A Prospective Controlled Trial of Routine Opt-Out HIV Testing in a Men's Jail

Background

Approximately 10 million Americans enter jails annually. The Centers for Disease Control and Prevention now recommends routine opt-out HIV testing in these settings. The logistics for performing routine opt-out HIV testing within jails, however, remain controversial. The objective of this study was to evaluate the optimal time to routinely HIV test newly incarcerated jail detainees using an opt-out strategy.

Methods

This prospective, controlled trial of routine opt-out HIV testing was conducted among 298 newly incarcerated male inmates in an urban men''s jail in New Haven, Connecticut. 298 sequential entrants to the men''s jail over a three week period in March and April 2008 were assigned to be offered routine opt-out HIV testing at one of three points after incarceration: immediate (same day, n = 103), early (next day, n = 98), or delayed (7 days, n = 97). The primary outcome was the proportion of men in each group consenting to testing.

Results

Routine opt-out HIV testing was significantly higher for the early (53%: AOR = 2.6; 95% CI = 1.5 to 4.7) and immediate (45%: AOR = 2.3; 95% CI = 1.3 to 4.0) testing groups compared to the delayed (33%) testing group. The immediate and early testing groups, however, did not significantly differ (p = 0.67). In multivariate analyses, factors significantly associated with routine opt-out HIV testing were assignment to the ‘early’ testing group (p = 0.0003) and low (bond ≥$5,000, immigration or federal charges or pre-sentencing >30 days) likelihood of early release (p = 0.04). Two subjects received preliminary positive results and one of them was subsequently confirmed HIV seropositive.

Conclusions

In this men''s jail where attrition was high, routine opt-out HIV testing was not only feasible, but resulted in the highest rates of HIV testing when performed within 24 hours of incarceration.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00624247","term_id":"NCT00624247"}}NCT00624247     

Towards Universal Voluntary HIV Testing and Counselling: A Systematic Review and Meta-Analysis of Community-Based Approaches

Background

Effective national and global HIV responses require a significant expansion of HIV testing and counselling (HTC) to expand access to prevention and care. Facility-based HTC, while essential, is unlikely to meet national and global targets on its own. This article systematically reviews the evidence for community-based HTC.

Methods and Findings

PubMed was searched on 4 March 2013, clinical trial registries were searched on 3 September 2012, and Embase and the World Health Organization Global Index Medicus were searched on 10 April 2012 for studies including community-based HTC (i.e., HTC outside of health facilities). Randomised controlled trials, and observational studies were eligible if they included a community-based testing approach and reported one or more of the following outcomes: uptake, proportion receiving their first HIV test, CD4 value at diagnosis, linkage to care, HIV positivity rate, HTC coverage, HIV incidence, or cost per person tested (outcomes are defined fully in the text). The following community-based HTC approaches were reviewed: (1) door-to-door testing (systematically offering HTC to homes in a catchment area), (2) mobile testing for the general population (offering HTC via a mobile HTC service), (3) index testing (offering HTC to household members of people with HIV and persons who may have been exposed to HIV), (4) mobile testing for men who have sex with men, (5) mobile testing for people who inject drugs, (6) mobile testing for female sex workers, (7) mobile testing for adolescents, (8) self-testing, (9) workplace HTC, (10) church-based HTC, and (11) school-based HTC. The Newcastle-Ottawa Quality Assessment Scale and the Cochrane Collaboration''s “risk of bias” tool were used to assess the risk of bias in studies with a comparator arm included in pooled estimates. 117 studies, including 864,651 participants completing HTC, met the inclusion criteria. The percentage of people offered community-based HTC who accepted HTC was as follows: index testing, 88% of 12,052 participants; self-testing, 87% of 1,839 participants; mobile testing, 87% of 79,475 participants; door-to-door testing, 80% of 555,267 participants; workplace testing, 67% of 62,406 participants; and school-based testing, 62% of 2,593 participants. Mobile HTC uptake among key populations (men who have sex with men, people who inject drugs, female sex workers, and adolescents) ranged from 9% to 100% (among 41,110 participants across studies), with heterogeneity related to how testing was offered. Community-based approaches increased HTC uptake (relative risk [RR] 10.65, 95% confidence interval [CI] 6.27–18.08), the proportion of first-time testers (RR 1.23, 95% CI 1.06–1.42), and the proportion of participants with CD4 counts above 350 cells/µl (RR 1.42, 95% CI 1.16–1.74), and obtained a lower positivity rate (RR 0.59, 95% CI 0.37–0.96), relative to facility-based approaches. 80% (95% CI 75%–85%) of 5,832 community-based HTC participants obtained a CD4 measurement following HIV diagnosis, and 73% (95% CI 61%–85%) of 527 community-based HTC participants initiated antiretroviral therapy following a CD4 measurement indicating eligibility. The data on linking participants without HIV to prevention services were limited. In low- and middle-income countries, the cost per person tested ranged from US$2–US$126. At the population level, community-based HTC increased HTC coverage (RR 7.07, 95% CI 3.52–14.22) and reduced HIV incidence (RR 0.86, 95% CI 0.73–1.02), although the incidence reduction lacked statistical significance. No studies reported any harm arising as a result of having been tested.

Conclusions

Community-based HTC achieved high rates of HTC uptake, reached people with high CD4 counts, and linked people to care. It also obtained a lower HIV positivity rate relative to facility-based approaches. Further research is needed to further improve acceptability of community-based HTC for key populations. HIV programmes should offer community-based HTC linked to prevention and care, in addition to facility-based HTC, to support increased access to HIV prevention, care, and treatment.

Review Registration

International Prospective Register of Systematic Reviews CRD42012002554 Please see later in the article for the Editors'' Summary     

Opt-Out and Opt-In Testing Increases Syphilis Screening of HIV-Positive Men Who Have Sex with Men in Australia

Background

Since 2005, Australian clinicians were advised to undertake quarterly syphilis testing for all sexually active HIV-positive men who have sex with men (MSM). We describe differences in syphilis testing frequency among HIV-positive MSM by clinic testing policies since this recommendation.

Methods

Three general practices, two sexual health clinics and two hospital HIV outpatient clinics provided data on HIV viral load and syphilis testing from 2006–2010. Men having ≥1 viral load test per year were included; >95% were MSM. We used Chi-2 tests to assess changes in syphilis testing frequency over time, and differences by clinic testing policy (opt-out, opt-in and risk-based).

Results

The proportion of men having HIV viral loads with same-day syphilis tests increased from 37% in 2006 to 63% in 2007 (p<0.01) and 68–69% thereafter. In 2010, same-day syphilis testing was highest in four clinics with opt-out strategies (87%, range:84–91%) compared with one clinic with opt-in (74%, p = 0.121) and two clinics with risk-based strategies (22%, range:20–24%, p<0.01). The proportion of men having ≥3 syphilis tests per year increased from 15% in 2006 to 36% in 2007 (p<0.01) and 36–38% thereafter. In 2010, the proportion of men having ≥3 syphilis tests in a year was highest in clinics with opt-out strategies (48%, range:35–59%), compared with opt-in (39%, p = 0.121) and risk-based strategies (8.4%, range:5.4–12%, p<0.01).

Conclusion

Over five years the proportion of HIV-positive men undergoing syphilis testing at recommended frequencies more than doubled, and was 5–6 times higher in clinics with opt-out and opt-in strategies compared with risk-based policies.     

Uptake of Home-Based Voluntary HIV Testing in Sub-Saharan Africa: A Systematic Review and Meta-Analysis

Introduction

Improving access to HIV testing is a key priority in scaling up HIV treatment and prevention services. Home-based voluntary counselling and testing (HBT) as an approach to delivering wide-scale HIV testing is explored here.

Methods and Findings

We conducted a systematic review and random-effects meta-analysis of studies published between 1 January 2000 and 24 September 2012 that reported on uptake of HBT in sub-Saharan Africa, to assess the proportion of individuals accepting HBT and receiving their test result.Our initial search yielded 1,199 articles; 114 were reviewed as full-text articles, and 19 publications involving 21 studies (n = 524,867 individuals offered HBT) were included for final review and meta-analysis. The studies came from five countries: Uganda, Malawi, Kenya, South Africa, and Zambia.The proportion of people who accepted HBT (n = 474,377) ranged from 58.1% to 99.8%, with a pooled proportion of 83.3% (95% CI: 80.4%–86.1%). Heterogeneity was high (τ² = 0.11). Sixteen studies reported on the number of people who received the result of HBT (n = 432,835). The proportion of individuals receiving their results out of all those offered testing ranged from 24.9% to 99.7%, with a pooled proportion of 76.7% (95% CI: 73.4%–80.0%) (τ² = 0.12). HIV prevalence ranged from 2.9% to 36.5%. New diagnosis of HIV following HBT ranged from 40% to 79% of those testing positive. Forty-eight percent of the individuals offered testing were men, and they were just as likely to accept HBT as women (pooled odds ratio = 0.84; 95% CI: 0.56–1.26) (τ² = 0.33). The proportion of individuals previously tested for HIV among those offered a test ranged from 5% to 66%. Studies in which <30% of individuals had been previously tested, local HIV prevalence was <10%, incentives were provided, or HBT was offered to household members of HIV-positive individuals showed higher uptake of testing. No evidence was reported of negative consequences of HBT.

Conclusions

HBT could substantially increase awareness of HIV status in previously undiagnosed individuals in sub-Saharan Africa, with over three-quarters of the studies in this review reporting >70% uptake. It could be a valuable tool for treatment and prevention efforts. Please see later in the article for the Editors'' Summary     

Provider-Initiated HIV Testing and Counselling in Rwanda: Acceptability among Clinic Attendees and Workers,Reasons for Testing and Predictors of Testing

Introduction

Routine provider-initiated HIV testing and counselling (PITC) may increase HIV testing rates, but whether PITC is acceptable to health facility (HF) attendees is unclear. In the course of a PITC intervention study in Rwanda, we assessed the acceptability of PITC, reasons for being or not being tested and factors associated with HIV testing.

Methods

Attendees were systematically interviewed in March 2009 as they left the HF, regarding knowledge and acceptability of PITC, history of testing and reasons for being tested or not. Subsequently, PITC was introduced in 6 of the 8 HFs and a second round of interviews was conducted. Independent factors associated with testing were analysed using logistic regression. Randomly selected health care workers (HCWs) were also interviewed.

Results

1772 attendees were interviewed. Over 95% agreed with the PITC policy, both prior to and after implementation of PITC policy. The most common reasons for testing were the desire to know one’s HIV status and having been offered an HIV test by an HCW. The most frequent reasons for not being tested were known HIV status and test not being offered. In multivariable analysis, PITC, age ≥15 years, and not having been previously tested were factors significantly associated with testing. Although workload was increased by PITC, HIV testing rates increased and HCWs overwhelmingly supported the policy.

Conclusion

Among attendees and HCWs in Rwandan clinics, the acceptability of PITC was very high. PITC appeared to increase testing rates and may be helpful in prevention and early access to treatment.     

Voluntary Medical Male Circumcision Programs Can Address Low HIV Testing and Counseling Usage and ART Enrollment among Young Men: Lessons from Lesotho

Background

Early diagnosis of HIV and treatment initiation at higher CD4 counts improves outcomes and reduces transmission. However, Lesotho is not realizing the full benefits of ART because of the low proportion of men tested (40%). Public sector VMMC services, which were launched in district hospitals in February 2012 by the Lesotho MOH supported by USAID/MCHIP, include HIV testing with referral to care and treatment. The objective of this study was to better understand the contribution of VMMC services to HIV diagnosis and treatment.

Methods

VMMC clients diagnosed with HIV were traced after 6 months to ascertain whether they: (1) presented to the referral HIV center, (2) had a CD4 count done and (3) were enrolled on ART. Linkages between VMMC and HIV services were assessed by comparing the proportion of HIV-infected males referred from VMMC services with those from other hospital departments.

Results

Between March and September 2012, 72 men presenting for VMMC services tested positive for HIV, representing 65% of the total male tests at the hospital; 45 of these men (62.5%) received an immediate CD4 count and went to the HIV referral site; 40 (89%) were eligible for treatment and initiated ART. 27 clients did not have a CD4 count due to stock-out of reagents. Individuals who did not receive a CD4 count on the same day did not return to the HIV center.

Conclusion

All VMMC clients testing positive for HIV and receiving a CD4 count on the testing day began ART. Providing VMMC services in a district hospital offering the continuum of care could increase diagnoses and treatment uptake among men, but requires an investment in communication between VMMC and ART clinics. In high HIV prevalence settings, investing in PIMA CD4 devices at integrated VMMC clinics is likely to increase male ART enrolment.     

Opt-Out Panel Testing for HIV,Hepatitis B and Hepatitis C in an Urban Emergency Department: A Pilot Study

Objectives

Studies suggest 2 per 1000 people in Dublin are living with HIV, the level above which universal screening is advised. We aimed to assess the feasibility and acceptability of a universal opt-out HIV, Hepatitis B and Hepatitis C testing programme for Emergency Department patients and to describe the incidence and prevalence of blood-borne viruses in this population.

Methods

An opt-out ED blood borne virus screening programme was piloted from March 2014 to January 2015. Patients undergoing blood sampling during routine clinical care were offered HIV 1&2 antibody/antigen assay, HBV surface antigen and HCV antibody tests. Linkage to care where necessary was co-ordinated by the study team. New diagnosis and prevalence rates were defined as the new cases per 1000 tested and number of positive tests per 1000 tested respectively.

Results

Over 45 weeks of testing, of 10,000 patient visits, 8,839 individual patient samples were available for analysis following removal of duplicates. A sustained target uptake of >50% was obtained after week 3. 97(1.09%), 44(0.49%) and 447(5.05%) HIV, Hepatitis B and Hepatitis C tests were positive respectively. Of these, 7(0.08%), 20(0.22%) and 58(0.66%) were new diagnoses of HIV, Hepatitis B and Hepatitis C respectively. The new diagnosis rate for HIV, Hepatitis B and Hepatitis C was 0.8, 2.26 and 6.5 per 1000 and study prevalence for HIV, Hepatitis B and Hepatitis C was 11.0, 5.0 and 50.5 per 1000 respectively.

Conclusions

Opt-out blood borne viral screening was feasible and acceptable in an inner-city ED. Blood borne viral infections were prevalent in this population and newly diagnosed cases were diagnosed and linked to care. These results suggest widespread blood borne viral testing in differing clinical locations with differing population demographic risks may be warranted.     

Methadone Maintenance Treatment Promotes Referral and Uptake of HIV Testing and Counselling Services amongst Drug Users and Their Partners

BackgroundMethadone maintenance treatment (MMT) reduces HIV risk behaviors and improves access to HIV-related services among drug users. In this study, we assessed the uptake and willingness of MMT patients to refer HIV testing and counseling (HTC) service to their sexual partners and relatives.MethodsHealth status, HIV-related risk behaviors, and HTC uptake and referrals of 1,016 MMT patients in Hanoi and Nam Dinh were investigated. Willingness to pay (WTP) for HTC was elicited using a contingent valuation technique. Interval and logistic regression models were employed to determine associated factors.ResultsMost of the patients (94.2%) had received HTC, 6.6 times on average. The proportion of respondents willing to refer their partners, their relatives and to be voluntary peer educators was 45.7%, 35.3%, and 33.3%, respectively. Attending MMT integrated with HTC was a facilitative factor for HTC uptake, greater WTP, and volunteering as peer educators. Older age, higher education and income, and HIV positive status were positively related to willingness to refer partners or relatives, while having health problems (mobility, usual care, pain/discomfort) was associated with lower likelihood of referring others or being a volunteer. Over 90% patients were willing to pay an average of US $17.9 for HTC service.ConclusionThe results highlighted the potential role of MMT patients as referrers to HTC and voluntary peer educators. Integrating HIV testing with MMT services and applying users’ fee are potential strategies to mobilize resources and encourage HIV testing among MMT patients and their partners.     

Prevalence and Correlates of HIV Testing among Young People Enrolled in Non-Formal Education Centers in Urban Chiang Mai,Thailand: A Cross-Sectional Study

BackgroundHIV testing is the gateway to HIV prevention, treatment, and care. Despite the established vulnerability of young Thai people to HIV infection, studies examining the prevalence and correlates of HIV testing among the general population of Thai youth are still very limited. This study investigates socio-demographic, behavioral, and psychosocial factors associated with HIV testing among young Thai people enrolled in Non-formal Education Centers (NFEC) in urban Chiang Mai, Northern Thailand.MethodsThis was a cross-sectional quantitative study conducted among young unmarried Thai youth—between the ages of 15 and 24—who were enrolled in NFEC in urban Chiang Mai. Multiple logistic regressions were used to identify correlates of “ever tested for HIV” among the sexually active participants.FindingsOf the 295 sexually active participants, 27.3% reported “ever tested for HIV;” 65.4% “did not consistently use condom;” and 61.7% “had at least 2 lifetime partners.” We found that “self-efficacy” (AOR, 4.92; CI, 1.22–19.73); “perception that it is easy to find a location nearby to test for HIV” (AOR, 4.67; CI, 1.21–18.06); “having at least 2 lifetime sexual partners” (AOR, 2.05; CI, 1.09–3.85); and “ever been pregnant or made someone pregnant” (AOR, 4.06; CI, 2.69–9.15); were associated with increased odds of having ever been tested. On the other hand, “fear of HIV test results” (AOR, 0.21; CI, 0.08–0.57) was associated with lower odds of ever having been tested for HIV.ConclusionThe main finding is that a substantially high proportion of Thai youth is engaged in risky sexual behaviors—yet reports low rates of ever having been tested for HIV. This highlights an urgent need to develop appropriate interventions—based on the identified correlates of HIV testing. There is also an urgent need to enhance HIV testing and to promote safer sexual behaviors among young Thai people—particularly those who are out-of-school.     

Cost-Effectiveness of HIV Testing Referral Strategies among Tuberculosis Patients in India

Background

Indian guidelines recommend routine referral for HIV testing of all tuberculosis (TB) patients in the nine states with the highest HIV prevalence, and selective referral for testing elsewhere. We assessed the clinical impact and cost-effectiveness of alternative HIV testing referral strategies among TB patients in India.

Methods and Findings

We utilized a computer model of HIV and TB disease to project outcomes for patients with active TB in India. We compared life expectancy, cost, and cost-effectiveness for three HIV testing referral strategies: 1) selective referral for HIV testing of those with increased HIV risk, 2) routine referral of patients in the nine highest HIV prevalence states with selective referral elsewhere (current standard), and 3) routine referral of all patients for HIV testing. TB-related data were from the World Health Organization. HIV prevalence among TB patients was 9.0% in the highest prevalence states, 2.9% in the other states, and 4.9% overall. The selective referral strategy, beginning from age 33.50 years, had a projected discounted life expectancy of 16.88 years and a mean lifetime HIV/TB treatment cost of US$100. The current standard increased mean life expectancy to 16.90 years with additional per-person cost of US$10; the incremental cost-effectiveness ratio was US$650/year of life saved (YLS) compared to selective referral. Routine referral of all patients for HIV testing increased life expectancy to 16.91 years, with an incremental cost-effectiveness ratio of US$730/YLS compared to the current standard. For HIV-infected patients cured of TB, receiving antiretroviral therapy increased survival from 4.71 to 13.87 years. Results were most sensitive to the HIV prevalence and the cost of second-line antiretroviral therapy.

Conclusions

Referral of all patients with active TB in India for HIV testing will be both effective and cost-effective. While effective implementation of this strategy would require investment, routine, voluntary HIV testing of TB patients in India should be recommended.     

Young,Online and in the Dark: Scaling Up HIV Testing among MSM in ASEAN

BackgroundPoor HIV testing uptake by MSM may be attributable to unique challenges that are localized in Southeast Asia.ObjectiveTo characterize MSM who never tested for HIV, to identify correlates of never testing, and to elucidate the perceived barriers to HIV testing.MethodsThe present study used data from the Asian Internet MSM Sex Survey (AIMSS) and restricted the analysis to 4,310 MSM from the ten member countries of the Association of South East Asian Nations (ASEAN).ResultsAmong MSM participants from ASEAN in our sample, 1290 (29.9%) reported having never been tested for HIV, 471 (10.9%) tested for HIV more than 2 years ago, and 2186 (50.7%) reported their last test date was between 6 months and two years ago, with only 363 (8.4%) of these men having been tested in the past 6 months. In multivariable logistic regression, younger MSM (age 15–22 years old [AOR: 4.60, 95% CI: 3.04–6.96]), MSM with lower education (secondary school or lower [AOR: 1.37, 95% CI: 1.03–1.83]), MSM who identify as bisexual or heterosexual (compared to gay-identified) (AOR: 1.94, 95% CI: 1.60–2.35), and MSM who had never used a condom with male partners (AOR: 1.61, 95% CI: 1.32–1.97) had higher odds of never been HIV tested. Main reason for not being tested was a low risk perception of HIV exposure (n = 390, 30.2%).ConclusionCurrent HIV prevention response must not leave MSM “in the dark,” but instead meet them where they are by utilizing the Internet creatively through social media and smart phones. As ASEAN Economic Community (AEC) is quickly becoming a reality, so must there be an equally fast and united response to slowing down the HIV epidemics among MSM in ASEAN.     

Awareness of HIV Status,Prevention Knowledge and Condom Use among People Living with HIV in Mozambique

Objective

To determine factors associated with HIV status unawareness and assess HIV prevention knowledge and condom use among people living with HIV/AIDS (PLHIV) in Mozambique.

Design

Cross-sectional household-based nationally representative AIDS Indicator Survey.

Methods

Analyses focused on HIV-infected adults and were weighted for the complex sampling design. We identified PLHIV who had never been tested for HIV or received their test results prior to this survey. Logistic regression was used to assess factors associated with HIV status unawareness.

Results

Of persons with positive HIV test results (N = 1182), 61% (95% confidence interval [CI] 57–65%) were unaware of their serostatus. Men had twice the odds of being unaware of their serostatus compared with women [adjusted odds ratio (aOR) 2.05, CI 1.40–2.98]. PLHIV in the poorest wealth quintile were most likely to be unaware of their serostatus (aOR 3.15, CI 1.09–9.12) compared to those in the middle wealth quintile. Most PLHIV (83%, CI 79–87%) reported not using a condom during their last sexual intercourse, and PLHIV who reported not using a condom during their last sexual intercourse were more likely to be unaware of their serostatus (aOR 2.32, CI 1.57–3.43) than those who used a condom.

Conclusions

Knowledge of HIV-positive status is associated with more frequent condom use in Mozambique. However, most HIV-infected persons are unaware of their serostatus, with men and persons in the poorest wealth quintile being more likely to be unaware. These findings support calls for expanded HIV testing, especially among groups less likely to be aware of their HIV status and key populations at higher risk for infection.     

Pregnancy Incidence and Risk Factors among Women Participating in Vaginal Microbicide Trials for HIV Prevention: Systematic Review and Meta-Analysis

Introduction

Pregnancy is contraindicated in vaginal microbicide trials for the prevention of HIV infection in women due to the unknown maternal and fetal safety of the microbicides. Women who become pregnant are taken off the microbicide during pregnancy period but this result in reduction of the power of the trials. Strategies to reduce the pregnancy rates require an understanding of the incidence and associated risk factors of pregnancy in microbicide trials. This systematic review estimates the overall incidence rate of pregnancy in microbicide trials and describes the associated risk factors.

Methods

A comprehensive literature search was carried out to identify eligible studies from electronic databases and other sources. Two review authors independently selected studies and extracted relevant data from included studies. Meta-analysis of incidence rates of pregnancy was carried out and risk factors of pregnancy were reported narratively.

Results

Fifteen studies reporting data from 10 microbicide trials (N=27,384 participants) were included. A total of 4,107 participants (15.0%) fell pregnant and a meta-analysis of incidence rates of pregnancy from 8 microbicide trials (N=25,551) yielded an overall incidence rate of 23.37 (95%CI: 17.78 to 28.96) pregnancies per 100 woman-years. However, significant heterogeneity was detected. Hormonal injectable, intra-uterine device (IUD) or implants or sterilization, older age, more years of education and condom use were associated with lower pregnancy. On the other hand, living with a man, history of pregnancy, self and partner desire for future baby, oral contraceptive use, increased number of unprotected sexual acts and inconsistent use of condoms were associated with higher pregnancy.

Conclusions

The incidence rate of pregnancy in microbicide trials is high and strategies for its reduction are urgently required in order to improve the sample size and power of these trials.     

Effect of Text Message,Phone Call,and In-Person Appointment Reminders on Uptake of Repeat HIV Testing among Outpatients Screened for Acute HIV Infection in Kenya: A Randomized Controlled Trial

BackgroundFollowing HIV-1 acquisition, many individuals develop an acute retroviral syndrome and a majority seek care. Available antibody testing cannot detect an acute HIV infection, but repeat testing after 2–4 weeks may detect seroconversion. We assessed the effect of appointment reminders on attendance for repeat HIV testing.MethodsWe enrolled, in a randomized controlled trial, 18–29 year old patients evaluated for acute HIV infection at five sites in Coastal Kenya (ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01876199","term_id":"NCT01876199"}}NCT01876199). Participants were allocated 1:1 to either standard appointment (a dated appointment card) or enhanced appointment (a dated appointment card plus SMS and phone call reminders, or in-person reminders for participants without a phone). The primary outcome was visit attendance, i.e., the proportion of participants attending the repeat test visit. Factors associated with attendance were examined by bivariable and multivariable logistic regression.ConclusionsAppointment reminders through SMS, phone calls and in-person reminders increased the uptake of repeat HIV test by forty percent. This low-cost intervention could facilitate detection of acute HIV infections and uptake of recommended repeat testing.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01876199","term_id":"NCT01876199"}}NCT01876199     

Internet-Facilitated,Voluntary Counseling and Testing (VCT) Clinic-Based HIV Testing among Men Who Have Sex with Men in China

Objective

To explore the feasibility of using Internet outreach to encourage men who have sex with men (MSM) to get tested for HIV at voluntary counseling and testing (VCT) clinics in Beijing and Urumqi, China.

Methods

From June to August 2007, two volunteers contacted MSM using instant messaging, online chat rooms, mobile phone, and e-mail (active recruitment). Banners with study information were put at the front pages of three major Chinese gay websites (passive recruitment). Those contacted were offered a modest financial incentive to seek HIV testing at existing VCT clinics. Those who subsequently sought HIV testing services at VCT clinics and provided informed consent completed a questionnaire and a blood draw to test for HIV and syphilis.

Results

A total of 3,332 MSM were contacted and 429 attended VCT clinics. One out of every 4 men that were recruited through instant messaging actually went for HIV testing, while the recruitment yields for online gay chat rooms, mobile phone contact, and email were 1∶6, 1∶10, and 1∶140, respectively. The majority of participants (80%, 317/399) reported being motivated to seek HIV testing out of concern for their health, and only 3% (11/399) reported being motivated by the financial incentive. Active recruitment tend to recruit MSM who are younger (X² = 11.400, P = 0.001), never tested for HIV (X² = 4.281, P = 0.039), tested less often (X² = 5.638, P = 0.018).

Conclusion

Internet outreach is a promising way to encourage MSM to seek HIV testing at existing VCT clinics. Active recruitment can target MSM who are younger, never tested for HIV and tested less often.     

HIV Infection among Young People in Northwest Tanzania: The Role of Biological,Behavioural and Socio-Demographic Risk Factors

Background

Young people are at high risk of HIV and developing appropriate prevention programmes requires an understanding of the risk factors for HIV in this age group. We investigated factors associated with HIV among participants aged 15–30 years in a 2007–8 cross-sectional survey nested within a community-randomised trial of the MEMA kwa Vijana intervention in 20 rural communities in northwest Tanzania.

Methods

We analysed data for 7259(53%) males and 6476(47%) females. Using a proximate-determinant conceptual framework and conditional logistic regression, we obtained sex-specific Odds Ratios (ORs) for the association of HIV infection with socio-demographic, knowledge, behavioural and biological factors.

Results

HSV-2 infection was strongly associated with HIV infection (females: adjOR 4.4, 95%CI 3.2–6.1; males: adjOR 4.2, 95%CI 2.8–6.2). Several socio-demographic factors (such as age, marital status and mobility), behavioural factors (condom use, number and type of sexual partnerships) and biological factors (blood transfusion, lifetime pregnancies, genital ulcers, Neisseria gonorrhoeae) were also associated with HIV infection. Among females, lifetime sexual partners (linear trend, p<0.001), ≥2 partners in the past year (adjOR 2.0, 95%CI 1.4–2.8), ≥2 new partners in the past year (adjOR 1.9 95%CI 1.2, 3.3) and concurrent partners in the past year (adjOR 1.6 95%CI 1.1, 2.4) were all associated with HIV infection.

Conclusions

Efforts must be intensified to find effective interventions to reduce HSV-2. Effective behavioural interventions focusing on reducing the number of sexual partnerships and risk behaviour within partnerships are also needed. An increase in risky sexual behaviour may occur following marriage dissolution or when a young woman travels outside of her community and interventions addressing the needs of these subgroups of vulnerable women may be important.

Trial Registration

ClinicalTrial.gov {"type":"clinical-trial","attrs":{"text":"NCT00248469","term_id":"NCT00248469"}}NCT00248469.     

Comparison of Closed-Ended,Open-Ended,and Perceived Informed Consent Comprehension Measures for a Mock HIV Prevention Trial among Women in Tanzania

Verifying participant comprehension continues to be a difficult ethical and regulatory challenge for clinical research. An increasing number of articles assessing methods to improve comprehension have been published, but they use a wide range of outcome measures including open-ended, closed-ended, and self-perceived measures of comprehension. Systematic comparisons of different measures have rarely been reported. This study evaluated the likely direction of bias observed when using open-ended, closed-ended, and perceived ease of comprehension measures among women administered a mock informed consent process in Mwanza, Tanzania. Participants were randomized to either a closed-ended or an open-ended assessment of comprehension, administered the consent process for a hypothetical HIV prevention trial in Kiswahili, and then administered a comprehension assessment, per their randomization. They were then asked how easy or hard it was to understand each of the informed consent components measured in the comprehension assessment. Women in the closed-ended arm had significantly higher overall comprehension scores than in the open-ended arm. Perceived scores were significantly higher when compared to both open-ended and close-ended scores within arms but were similar between arms. Findings highlight the importance of comprehension assessments in complex clinical trials that go beyond asking participants if they understand or have any questions. They also indicate the need for continued exploration of objective measures of comprehension in international clinical research settings, so that points in need of clarification can be efficiently and effectively identified and addressed. Such measures would reduce burdens on both staff and participants that result from well-intentioned but potentially unnecessary time spent explaining in unwarranted detail things already understood.     

Comparing Cost-Effectiveness of HIV Testing Strategies: Targeted and Routine Testing in Washington,DC

BackgroundRoutine HIV testing is an essential approach to identifying undiagnosed infections, linking people to care and treatment, and preventing new infections. In Washington, DC, where HIV prevalence is 2.4%, a combination of routine and targeted testing approaches has been implemented since 2006.MethodsWe sought to evaluate the cost effectiveness of the District of Columbia (DC) Department of Health’s routine and targeted HIV testing implementation strategies. We collected HIV testing data from 3 types of DC Department of Health-funded testing sites (clinics, hospitals, and community-based organizations); collected testing and labor costs; and calculated effectiveness measures including cost per new diagnosis and cost per averted transmission.ResultsCompared to routine testing, targeted testing resulted in higher positivity rates (1.33% vs. 0.44%). Routine testing averted 34.30 transmissions per year compared to targeted testing at 17.78. The cost per new diagnosis was lower for targeted testing ($2,467 vs. $7,753 per new diagnosis) as was the cost per transmission averted ($33,160 vs. $104,205). When stratified by testing site, both testing approaches were most cost effective in averting new transmissions when conducted by community based organizations ($25,037 routine; $33,123 targeted) compared to hospitals or clinics.ConclusionsWhile routine testing identified more newly diagnosed infections and averted more infections than targeted testing, targeted testing is more cost effective per diagnosis and per transmission averted overall. Given the high HIV prevalence in DC, the DC Department of Health’s implementation strategy should continue to encourage routine testing implementation with emphasis on a combined testing strategy among community-based organizations.