Semen Washing and Intrauterine Insemination for Reducing the Risk of Human Immunodeficiency Virus Transmission in Serodiscordant Couples: A Cross-sectional Study.

Background: Antiretroviral therapy has helped human immunodeficiency virus (HIV)-infected people live an enhanced quality of life and attempt for a pregnancy, without placing their partner at risk. Although periconceptional pre-exposure prophylaxis for the uninfected partner and consistent antiretroviral therapy for the HIV-infected partner are important to prevent HIV transmission, semen washing could be a great option to further reduce the semen viral load. Aim: The aim of this study were as follows: to determine if semen washing with intrauterine insemination provides an added safety net to HIV-serodiscordant couples when the male partner is HIV-infected and virally suppressed and to determine if the U = U concept (undetectable = untransmittable) holds true in virally suppressed HIV-infected males. Settings and Design: This was an observational study conducted in seropositive HIV men under treatment with highly active antiretroviral therapy (HAART) in collaboration with Metropolis Laboratory, a CAP recognised private Healthcare Laboratory in Mumbai, India. Materials and Methods: Blood and semen samples were collected from a total of 110 adult HIV-1-infected males virally suppressed on HAART. These samples were processed to assess the viral load in plasma as well as raw and processed semen fractions. Statistical Analysis Used: Descriptive statistics were used to analyse the data. Results: Only men with plasma viral loads < 1000 copies were selected in our study. Out of the 110 HIV-infected individuals, 102 (92.73%) patients had undetectable (<20 copies/ml) plasma viral load while 8 (7.27%) patients had a detectable (>20 copies/ml) viral load, who were excluded from the study. In the virally suppressed 102 men, the raw semen samples of 100 men showed an undetectable viral load, while 2 samples showed detectable contamination, even though their plasma samples from the blood showed a viral load of <20 copies/ml. The semen was then separated into the sperm and the seminal plasma samples. The seminal plasma had <20 copies/ml in 95 samples (93.14%) but a detectable viral load in 7 (6.86%) samples. After subjecting all the 102 processed (post-wash) sperm samples to quantitative analysis, an undetectable viral load of <20 copies/ml was found in all the samples. Thus, the raw sample (prewashed),seminal plasma and processed (postwash) samples were evaluated. The post-wash sperm sample showing zero contamination was frozen for intrauterine insemination (IUI) in the uninfected female partner. Conclusions: Semen washing with IUI should be advocated as a safe, efficacious way to increase the safety net and to further reduce the minimal risk of HIV transmission in serodiscordant couples in addition to the U = U concept.

Dyadic typology of illness perceptions in human immunodeficiency virus (HIV) Serodiscordant couples.

OBJECTIVE: Illness perceptions direct coping resources in the illness adaptation process. Previous studies regarding illness perception profiles have been conducted at the individual level, without considering the couple as a unit. This study aimed to investigate the dyadic topologies of illness perceptions in HIV-serodiscordant couples and the association between the identified profiles and individual- and couple-level outcomes. METHODS: A comprehensive examination was undertaken, encompassing 231 Chinese HIV-serodiscordant couples, who voluntarily participated in this cross-sectional study during the period spanning June to October 2022. To discern various patterns of illness perception, dyadic latent profile analyses were performed, followed by the implementation of one-way analyses of variance to investigate outcome differences at both the individual and couple levels across the identified profiles. RESULTS: We identified three distinct profiles of illness perception, namely the incongruent-but-low, congruent-but-high, and incongruent-and-high profiles. Except for the partner's sex (p < .01, Cramer' v = 0.214) and the education levels of persons living with HIV and their partners (both p < .01, Cramer' v = 0.236 for persons living with HIV and 0.198 for partners), no significant demographic differences across the various profiles were found. Furthermore, we observed significant differences in all outcomes among the different couple profiles (all p < .001). These differences were of medium-to-large magnitudes (partial η2 values ranging from 0.07 to 0.22). CONCLUSION: A couple-centered typological approach provides a useful way of identifying the couple's configuration of illness perceptions, which will inform the provision of tailor-made treatment for couples with different profiles.

Agreements, Behaviour, and Change: Sex Outside the Relationship in Male HIV-negative Partners in HIV Serodiscordant Relationships in Australia, Brazil, and Thailand.

Male HIV serodiscordant couples have diverse relationship agreements regarding sex outside the relationship. We examined the relationship agreements as described by 343 male HIV-negative partners in HIV serodiscordant relationships in Australia, Brazil and Thailand participating in a multi-year cohort study. At baseline, 125 (34.1%) HIV-negative partners reported no agreement, 115 (33.5%) had a monogamous agreement, and 103 (37.9%) had an open agreement allowing sex outside the relationship. Relationship agreements were largely stable over time, with 76% of HIV-negative men reporting the same agreement across follow up, while changes were predominantly towards having an open agreement. Behaviour largely matched relationship agreements, and the predictors of breaking an agreement by having condomless anal intercourse (CLAI) with an outside partner were CLAI within the relationship (OR = 3.17, 95%CI: 1.64-6.14, p < 0.001) and PrEP use in the last three months (OR = 3.42, 95%CI: 1.48-7.92, p = 0.004). When considering HIV transmission risk for HIV-negative men in serodiscordant relationships, greater focus needs to be placed on sex that is occurring outside the relationship and the agreements that facilitate this.

Provider perspectives on service delivery modifications to maintain access to HIV pre-exposure prophylaxis during the COVID-19 pandemic: qualitative results from a PrEP implementation project in Kenya.

INTRODUCTION: HIV pre-exposure prophylaxis (PrEP) is an essential prevention strategy being scaled up for priority populations in Kenya, including for HIV serodiscordant couples. The COVID-19 pandemic posed challenges to PrEP rollout. We conducted a qualitative study of PrEP providers to understand how clinics adjusted PrEP delivery during the COVID-19 pandemic. METHODS: Since 2017, the Partners Scale-Up Project has integrated PrEP into 25 HIV clinics in Central and Western Kenya. We conducted qualitative interviews with 40 purposively sampled clinic personnel. We interviewed personnel once during the first pandemic wave (May-Aug 2020) and again after some decline in COVID-19 rates (Nov-Jan 2021). We analysed data using inductive memo-writing and summarized data by themes along the PrEP delivery cascade, guided by the Framework for Reporting Adaptation and Modifications (FRAME). RESULTS: We interviewed 27 clinical officers, five nurses, four health records and information officers, and four counsellors from Central (n = 20) and Western (n = 20) Kenya. About half (n = 19) were female, with a median age of 32 (IQR: 29-34) and 2.3 years of experience delivering PrEP (IQR: 2-3). All participants reported clinic changes in PrEP demand creation and service delivery during the pandemic. Modifications occurred during PrEP implementation and sustainment phases, were partly reactive to the pandemic and also facilitated by interim Ministry of Health guidance on PrEP delivery during COVID, and were made by PrEP delivery teams, clients and clinic managers. Commonly reported modifications included dispensing multiple-month PrEP refills, intensifying phone-based client engagement and collaborating with other HIV clinics to ensure that clients with prolonged stays in other regions could continue to access PrEP. Some clinics also adopted practices to streamline visits, such as within clinical-room PrEP dispensing, pre-packing PrEP and task-shifting. Most providers liked these changes and hoped they would continue after the pandemic subsides. CONCLUSIONS: COVID-19 served as a catalyst for PrEP delivery innovations in Kenya. HIV clinics successfully and rapidly adapted their PrEP demand creation, refill and retention strategies to promote PrEP uptake and effective use. These modified implementation strategies highlight opportunities to streamline the delivery of PrEP, as well as other HIV and chronic care services, and strengthen engagement with populations post-pandemic.

Health Care Worker Perspectives of HIV Pre-exposure Prophylaxis Service Delivery in Central Uganda.

Background: Scale-up of HIV pre-exposure prophylaxis (PrEP) services in Uganda is ongoing. However, health care workers (HCWs) may not be aware of PrEP nor what offering this service entails. We explored the impact of standardized HCW training on the knowledge and perspectives of PrEP service delivery in Uganda. Methods: We recruited HCWs from facilities that offered HIV-related services in Central Uganda. Using the Uganda Ministry of Health curriculum, we trained HCWs on PrEP services. We collected data about PrEP knowledge, preparedness, and willingness to deliver PrEP to multiple key populations before the training, immediately after the training, and >6 months later (exit). We additionally conducted 15 qualitative interviews after the exit survey. Quantitative data were analyzed by Fisher exact test, while qualitative interview data were analyzed inductively. Results: We recruited 80 HCWs from 35 facilities in urban (N = 24, 30%), peri-urban (N = 30, 37%), and rural (N = 26, 33%) areas. Most HCWs were nurse counselors (N = 52, 65%) or medical/clinical officers (N = 15, 18%). Surveys indicated that awareness of PrEP increased after the training and remained high. Knowledge of PrEP (i.e., as an effective, short-term antiretroviral medication to use before HIV exposure for people at high risk) generally increased with training, but significant gaps remained, and knowledge decreased with time. Most HCWs recommended PrEP for female sex workers and HIV serodifferent couples, as well as other key populations. We observed increases in the number of HCW who felt their facility was prepared to cater for HIV prevention and provide PrEP, but this view was not universal. HCWs believed in PrEP effectiveness and embraced it as an additional HIV prevention method. Concerns included patient adherence and behavioral risk compensation. HCWs noted challenges in PrEP delivery in terms of inadequate clinic preparedness, infrastructure, staff capacity, and poor attitudes toward key populations by untrained health workers. They felt further training was needed to ensure a smooth scale-up of services without stigmatization. Conclusions: Standardized training improved knowledge, willingness, and preparedness to offer PrEP services among most HCWs in Central Uganda. Ongoing training will be needed to optimize PrEP delivery services and expand delivery to levels needed for population-level impact.

Untapped Potential for Safer Conception Messaging to Transform PrEP Rollout and Promote Service Engagement Among Serodiscordant Couples.

Uptake of pre-exposure prophylaxis (PrEP) fell short of targets for Sub-Saharan Africa's initial rollout, revealing the need for more effective promotion strategies. In Uganda, we explored potential benefits and challenges of integrating safer conception messaging to promote PrEP among serodiscordant couples. In-depth interviews were conducted with clients and personnel at three clinics and analyzed thematically. Participants (n = 58) valued PrEP as a safer conception method (SCM) but described lack of integration of safer conception and PrEP services as well as inconsistent practices in prescribing PrEP to couples pursuing conception. Participants reported that the wider population remains largely unaware of PrEP and SCM or harbors misconceptions that PrEP is primarily for highly stigmatized groups like sex workers. Participants further described how heterosexual couples can still be reluctant to test for HIV, unaware of tools like PrEP and SCM that would allow them to continue their relationship and/or pursuit of childbearing. Overall, findings suggest that integrating PrEP and SCM in messaging and services targeting serodiscordant couples holds untapped benefits throughout the HIV prevention cascade.

Serodiscordance predictors among couples in the HIV context: implications for health care.

BACKGROUND: After HIV diagnosis, people maintain, reestablish their sexual lives, or build new relationships, often with HIV seronegative partners. Therefore, understanding the factors concerning couple-vulnerability is essential in order to design effective HIV preventive strategies. We examined HIV serodiscordant couples prevalence and their associated factors from a Brazilian city. METHODS: This is a cross-sectional analytical study carried out with people living with HIV (PLHIV) who had an active sex life and were engagement in HIV health care follow-up. Data were collected using a semi-structured questionnaire during individual interviews. We analyzed data using bivariate and multiple logistic regression analyses. RESULTS: There was 72.0% of HIV serodiscordant partnerships. Those who inconsistently used condoms (aOR: 0.3[0.13-0.7]) and/or had HIV detectable viral load (aOR: 0.29 [0.12-0.7]) were less likely to have an HIV serodiscordant sexual partner. On other hand, the lack of HIV transmission counseling by the health service (aOR: 5.08 [2.02-12.76]), or those who had a casual partner (aOR: 8.12 [1.7-38.8]) or a steady and casual one concomitantly (aOR: 24.82 [1.46-420.83]), were more likely to indicate an HIV serodiscordant partnership. CONCLUSION: The findings showed a high prevalence of serodiscordant partnerships in PLHIV. Greater visibility among couples in the health services is needed as well as a reassessment in order to provide PLHIV and their sexual partners with care strategies, by the health professionals.

Characteristics of Agreements to have Condomless Anal Intercourse in the Presence of an Undetectable Viral Load Among HIV Serodiscordant Male Couples in Australia, Brazil and Thailand.

The use of undetectable viral load (VL) to negotiate condomless anal intercourse (CLAI) in HIV serodiscordant male relationships has become more common as more data regarding the effectiveness of antiretroviral treatments for the prevention of HIV transmission has been described. We examined viral load agreements (VLAs) for condomless sex in the presence of an undetectable VL in 343 HIV serodiscordant male couples in Australia, Brazil and Thailand. Factors associated with having a VLA included having agreements for the HIV-positive partner to report his VL result (p < 0.001), agreeing that VL affects agreements about sexual practice (p < 0.001), the HIV-negative partner's perception of his partner's undetectable VL (p < 0.001), the couple's belief in the efficacy of undetectable VL in preventing HIV transmission (p < 0.001), and the couple engaging in CLAI with each other (p < 0.001). Over time, these agreements became more common although 49.3% of couples in the sample never had a viral load agreement. As these agreements become more common, further education is required to support male couples in using them safely.

"Our Choice" improves use of safer conception methods among HIV serodiscordant couples in Uganda: a cluster randomized controlled trial evaluating two implementation approaches.

BACKGROUND: Safer conception counseling (SCC) to promote the use of safer conception methods (SCM) is not yet part of routine family planning or HIV care. Guidelines for the use of SCM have been published, but to date there are no published controlled evaluations of SCC. Furthermore, it is unknown whether standard methods commonly used in resource constrained settings to integrate new services would be sufficient, or if enhanced training and supervision would result in a more efficacious approach to implementing SCC. METHODS: In a hybrid, cluster randomized controlled trial, six HIV clinics were randomly assigned to implement the SCC intervention Our Choice using either a high (SCC1) or low intensity (SCC2) approach (differentiated by amount of training and supervision), or existing family planning services (usual care). Three hundred eighty-nine HIV clients considering childbearing with an HIV-negative partner enrolled. The primary outcome was self-reported use of appropriate reproductive method (SCM if trying to conceive; modern contraceptives if not) over 12 months or until pregnancy. RESULTS: The combined intervention groups used appropriate reproductive methods more than usual care [20.8% vs. 6.9%; adjusted OR (95% CI)=10.63 (2.79, 40.49)], and SCC1 reported a higher rate than SCC2 [27.1% vs. 14.6%; OR (95% CI)=4.50 (1.44, 14.01)]. Among those trying to conceive, the intervention arms reported greater accurate use of SCM compared to usual care [24.1% vs. 0%; OR (95% CI)=91.84 (4.94, 1709.0)], and SCC1 performed better than SCC2 [34.6% vs. 11.5%; OR (95% CI)=6.43 (1.90, 21.73)]. The arms did not vary on modern contraception use among those not trying to conceive. A cost of $631 per person was estimated to obtain accurate use of SCM in SCC1, compared to $1014 in SCC2. CONCLUSIONS: More intensive provider training and more frequent supervision leads to greater adoption of complex SCM behaviors and is more cost-effective than the standard low intensity implementation approach. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03167879 ; date registered May 23, 2017.

"Now that PrEP is reducing the risk of transmission of HIV, why then do you still insist that we use condoms?" the condom quandary among PrEP users and health care providers in Kenya.

Communication around condom use in the context of PrEP services presents a potential conundrum for patients and providers. Within the Partners Scale-Up Project, which supports integration of PrEP delivery in HIV care clinics, we interviewed 41 providers and 61 PrEP users and identified themes relating to condom messaging and use. Most providers counselled PrEP initiators to always use both PrEP and condoms, except when trying to conceive. However, others reported contexts and rationales for not emphasizing condom use. Providers reported that PrEP users were sometimes confused, even frustrated, with their insistence on using condoms in addition to PrEP. PrEP users generally regarded PrEP as a more feasible and desirable HIV prevention method than condoms, enabling increased sexual pleasure and conception, and reducing the conflict and stigma associated with condom use. Innovative approaches to condom counselling in PrEP programs are needed.

The relationship between dyadic coping and dyadic adjustment among HIV-serodiscordant couples.

Living within an HIV-serodiscordant relationship has been recognized as a stressful experience for both HIV-infected and HIV-uninfected partners. However, no study has examined the association between dyadic coping (DC) and dyadic adjustment of such couples. In this study, we analysed the association between DC (positive, negative, and common DC) and dyadic adjustment (consensus, satisfaction, cohesion) among HIV-serodiscordant couples, considering individual and cross-partner effects. This cross-sectional study included a sample of 44 HIV-serodiscordant different-sex couples, in a relationship for an average of 16.46 years. The self-reported measures included the Dyadic Coping Inventory and the Revised Dyadic Adjustment Scale. For HIV-infected partners, their own common DC was significantly associated with cohesion, and a cross-partner effect of common DC on satisfaction was found. For HIV-uninfected partners, individual effects of common DC on all dyadic adjustment subscales and a cross-partner effect of common DC on cohesion were found. Additionally, their own and their HIV-infected partners' negative DC were significantly associated with cohesion and satisfaction, respectively. These findings suggest that the perception of common DC has a particularly important role in explaining the different components of dyadic adjustment of both partners facing HIV-serodiscordancy, whereas negative DC is linked to the adjustment of HIV-uninfected partners.

Psychosocial Factors, Condomless Sex, and Detectable Viral Load in HIV-Positive Women in Serodiscordant Couples in Nairobi, Kenya.

This prospective study of HIV-positive Kenyan women in serodiscordant couples examined relationships between psychosocial factors, viral suppression, and condomless sex. Participants were screened for alcohol use disorders and intimate partner violence (IPV) annually and depressive symptoms every 6 months. Prostate specific antigen (PSA) detection was used as a marker for condomless sex. A total of 151 participants contributed 349 person-years of follow-up. Hazardous/harmful alcohol use was associated with increased risk of detecting PSA in vaginal secretions (aRR 1.99, 95%CI 1.08-3.66, χ2 = 4.85 (1)), while IPV and depression were not. Events representing HIV transmission potential, where there was biological evidence of condomless sex at a visit with a detectable plasma viral load, were observed at 2% of visits. The high prevalence of IPV and association between alcohol use and sexual risk suggest the need for monitoring and support for these conditions as part of comprehensive HIV care for women.

Barriers to Testing for Sexually Transmitted Infections among HIV-Serodiscordant Couples: The Influence of Discrimination.

Objectives: African Americans face challenges in accessing services for sexually transmitted infections (STIs). From 2012-2016, the EBAN II intervention was funded by the NIH to test the effectiveness of implementing a culturally congruent, evidence-based HIV/AIDS prevention program in Los Angeles and Oakland, California. This study examined the impact of personal characteristics and experiences of discrimination on the likelihood of being tested for STIs. Methods: Participants (N=91) completed a baseline survey. Descriptive statistics were used to test for differences between those who did and did not obtain STI testing. Factors included HIV serostatus, sociodemographic variables, STI history, the presence of outside partners, and discrimination experiences. Multiple logistic regressions were conducted for men and women separately. Results: Participants with no recent experiences of discrimination were more than 3 (3.4) times more likely to obtain a baseline STI test than those who reported discrimination experiences. HIV-positive women with no recent experiences of discrimination were 11 times more likely than those with reports of recent discrimination to obtain STI tests. Conclusions: It is often women who are the gatekeepers for health seeking in families and the same may be for these couples. Experiences of discrimination may impede STI testing, and heighten several health risks, particularly among HIV-positive African American women in HIV-serodiscordant relationships. Addressing the impact of discrimination experiences may be important for STI prevention and treatment efforts in interventions promoting health care utilization.

"I just believe there is a risk" understanding of undetectable equals untransmissible (U = U) among health providers and HIV-negative partners in serodiscordant relationships in Kenya.

INTRODUCTION: Sustained HIV viral suppression resulting from antiretroviral therapy (ART) eliminates the risk of HIV transmission, a concept popularly framed as Undetectable = Untransmittable (U = U). We explored knowledge and acceptance of information around the elimination of HIV transmission risk with ART (U = U) in Kenya. METHODS: Our qualitative study was conducted within a project evaluating the use of pre-exposure prophylaxis (PrEP) integrated into ART care for HIV serodiscordant couples in public clinics in Kenya (the Partners Scale Up Project). From February 2017 to April 2019, we conducted semi-structured key informant interviews with 83 health providers and in-depth interviews with 61 HIV-negative people in serodiscordant relationships receiving PrEP services. Transcripts were coded using thematic analysis. RESULTS: Health providers reported being aware of reduced risk of HIV transmission as a result of consistent ART use and used words such as "very low," "minimal" and "like zero" to describe HIV transmission risk after viral suppression. Providers reported finding viral load results helpful when counselling clients about the risk of HIV transmission. Many lacked confidence in U = U and counselled on consistent condom use even after viral suppression while some expressed concerns that communicating this message to people living with HIV (PLHIV) would lead them to engage in multiple sexual relationships. Other providers reported that they did not counsel about the reduced risk of HIV transmission after viral suppression for fear of being blamed if HIV transmission occurred. HIV-negative partners reported being informed about U = U by providers but they did not believe nor trust the message. Even after their partners achieved viral suppression, some HIV-negative partners were unwilling to stop PrEP, while others indicated that they would use condoms if they stopped PrEP to be sure that they were protected from HIV. CONCLUSIONS: Despite awareness that effective ART use eliminates HIV transmission risk, there is both a lack of in-depth knowledge and conviction about the strategy among health providers and HIV-negative partners in serodiscordant relationships. New strategies that go beyond communicating the science of U = U to consider the local social and clinical environments could maximize the effectiveness of U = U.

No Evidence of Sexual Risk Compensation Following PrEP Initiation Among Heterosexual HIV Serodiscordant Couples in Kenya and Uganda.

Recent studies among men who have sex with men suggest that sexual behaviors associated with risk of sexually transmitted infections increase following initiation of pre-exposure prophylaxis (PrEP) for HIV prevention. We used longitudinal data from HIV-uninfected participants (n = 1013) enrolled in an open-label study of PrEP delivered to Ugandan and Kenyan heterosexual HIV serodiscordant couples to understand the association between PrEP initiation and HIV risk-related sexual behaviors among these couples. In the month following PrEP initiation, the mean number of monthly sex acts within couples decreased from 7.9 to 6.9 (mean difference: - 1.1; 95% CI - 1.5, - 0.7) and the proportion of couples having condomless sex decreased from 65% to 32% (percentage point change: - 33%; 95% CI - 37%, - 30%); these behaviors then remained relatively constant over 2 years. We found no evidence of sexual risk compensation following PrEP initiation within African serodiscordant couples. However, roughly a third of couples continued to engage in condomless sex during follow up, emphasizing the importance of continued PrEP use to sustain HIV protection.

Prevention of HIV Transmission and the HPTN 052 Study.

The HIV Prevention Trials Network 052 study (HPTN 052) was a clinical trial designed to determine whether early treatment for HIV infection prevented transmission of the virus in couples where one partner was infected with HIV and the other was not, referred to as HIV serodiscordant or serodifferent couples. The study enrolled 1,763 couples at 13 sites in 9 countries in Asia, Africa, and the Americas. HPTN 052 demonstrated a minimum of 96% reduction of HIV in heterosexual couples ascribed to antiretroviral treatment; early treatment of HIV significantly reduced other infections in the HIV-infected subjects. This study, in conjunction with similar research, led to significant changes in international HIV treatment guidelines and the concept of treatment as prevention (TasP). This article provides the scientific background and history of how HPTN 052 came into being, the challenges it faced, and the ultimate impact it had on the fields of HIV treatment and prevention.

Effectiveness of an HIV-risk reduction intervention to reduce HIV transmission among serodiscordant couples in Durban, South Africa. A randomized controlled trial.

Lack of condom use by married or cohabiting couples in populations with high rates of HIV infection has become a significant public health issue. This study investigated whether an HIV risk-reduction intervention (RRI) would increase condom use when delivered to serodiscordant couples as a unit. Of the 62 couples that were screened, 30 serodiscordant couples were enrolled in the study, and randomized 2:1 to an immediate intervention-waitlist control study. The 12-week intervention focused on communication, problem-solving, and negotiation skills. Participants were assessed at baseline, three and six months after the intervention. The main outcome measures were consistent condom use, HIV seroconversion and fidelity to the programme. The use of condoms increased for both the intervention and control groups after receiving a 12-week RRI. Group comparisons showed a significant difference at three months, with a significantly higher mean proportion of condom-protected sex acts (p = 0.0119) between the control and intervention groups, the later showing an increase in condom use. No seroconversion was detected, and the overall retention rate of participants was 83.33%. Counselling heterosexual couples as a unit prompted an increase in condom use, but sustained condom use remains a challenge.

Natural Conception is Safe for HIV-Serodiscordant Couples with Persistent Suppressive Antiretroviral Therapy for the Infected Partner.

Background: Sustained use of antiretroviral treatment to achieve a suppressed viral load in persons living with HIV is associated with zero or near-zero risk of sexual and vertical HIV transmission. This has led to an increasing number of HIV-serodiscordant couples (SDCs) who wish to have children. The aim of this study was to describe the most recent results of a protocol for reproductive counseling directed at HIV-SDCs who desire natural conception and to identify some of the factors influencing reproductive success. Methods: Two hundred fourteen couples were enrolled. Sociodemographic/behavioral and clinical data were collected. CD4+ lymphocyte count, HIV viral load, serology/viral load of hepatitis B/C viruses, syphilis serology, and other sexually transmitted infection diagnosis in both members of couple; spermiogram in men, HIV proviral and viral load in semen of male HIV-infected partners, and urine luteinizing hormone qualitative test in women were performed. Unprotected vaginal intercourses, pregnancies achieved, and their outcomes were recorded. Results: After almost 10,000 sexual relations, a total of 188 pregnancies was achieved, 62% of couples became pregnant once or several times with no HIV transmission to either the partner or the offspring. Younger age of woman, no fertility disorders in both members of couple, and no treatment with efavirenz in men were factors related with reproductive success. Conclusions: Natural conception, under controlled conditions, can be offered to SDCs who wish to have children as a safe method of conception and its effectiveness seems to be related to factors not different from those of the general population.

HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya.

BACKGROUND: The introduction of pre-exposure prophylaxis (PrEP) for human immunodeficiency virus-1 (HIV-1) prevention in Africa presents new challenges for health systems that are already overburdened because PrEP delivery requires frequent clinic visits (generally every 3 months) for HIV-1 testing and PrEP refills. HIV-1 self-testing (HIVST) has the potential to improve the efficiency of PrEP delivery by decreasing the number of clinic visits. Here, we describe the rationale and design of a randomized, noninferiority trial designed to test the effectiveness and safety of using HIVST to support PrEP delivery in Kenya. METHODS: The JiPime-JiPrEP (Kiswahili for 'Test Yourself, PrEP Yourself') study is a three-arm randomized trial taking place in Thika, Kenya. Participants (n = 495) are eligible for enrollment if they are at least 18 years old, HIV-1 seronegative, and have been taking PrEP for 1 month. Three distinct participant types will be enrolled: men (n = 165) and women (n = 165) who are in mutually disclosed HIV-1 serodiscordant relationships, and women (n = 165) who are at HIV-1 risk and not in a known serodiscordant relationship. Participants in each of these subpopulations will be 1:1:1 randomized to: 1) the standard of care, with quarterly clinic visits; 2) oral HIVST, with biannual clinic visits plus oral HIVSTs to use at the quarters between those visits; or 3) blood-based HIVST, with biannual clinic visits plus blood-based HIVSTs. All participants will complete quantitative surveys and provide blood samples for the objective measurement of PrEP adherence at baseline, 6 months, and 12 months. The primary outcomes are PrEP adherence, PrEP continuation, and HIV-1 testing, measured at 6 months and secondarily at 12 months. DISCUSSION: The findings from this trial can help to understand how HIVST-a new HIV-1 testing technology-can support health systems in sub-Saharan Africa. Additionally, the findings can inform policy aimed at improving the efficiency of PrEP implementation and scale-up in Kenya. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03593629 . Retrospectively registered on 20 July 2018.

A Cost and Cost-Threshold Analysis of Implementation of an Evidence-Based Intervention for HIV-Serodiscordant Couples.

To address gaps in the cost literature by estimating the cost of delivering an evidence-based HIV risk reduction intervention for HIV-serodiscordant, heterosexual, African American couples (Eban II) and calculating the cost-effective thresholds at three participating sites. The cost, cost-saving, and cost-effectiveness thresholds for Eban II were calculated using standard methods. The analytic time period was from July 1 to September 31, 2014. Total costs for 3 months of program implementation were from $13,747 to $25,937, with societal costs ranging from $5632 to $17,008 and program costs ranging from $8115 to $14,122. The costs per participant were from $1621 to $2160; the cost per session (per participant) ranged from $147 to $196. Sites had achievable cost-saving thresholds, which were all less than one for the 3-month costing timeframe.