Risk Compensation After Initiation of Daily Oral Pre-exposure Prophylaxis Among Sexual and Gender Minorities in Nigeria.

Pre-exposure prophylaxis (PrEP) use may be associated with risk compensation. We enrolled and provided PreP to sexual and gender minorities (SGM) in Abuja, Nigeria between April 2018 and May 2019. Behavioral information and samples for urogenital and anorectal Chlamydia trachomatis and Neisseria gonorrhoeae sexually transmitted infections (STIs) were collected at baseline. Blood samples for PrEP assay and self-reported adherence were collected at three-monthly follow-up visits. STIs were detected using Aptima Combo2 assay. We estimated the odds ratios (ORs) of PCR-diagnosed bacterial STIs and self-reported behavioral outcomes (condomless anal intercourse [CAI] and concurrent sexual relationships) with conditional logistic regression. Of 400 SGM who initiated PrEP, 206 were eligible for analysis, and had a median age of 24 years (IQR 22-27). In multivariable analysis, participants in the PrEP period had decreased odds of CAI (adjusted OR: 0.49, 95% CI 0.28, 0.84). PrEP use was not associated with risk compensation.

Hepatitis B virus infection among men who have sex with men and transgender women living with or at risk for HIV: a cross sectional study in Abuja and Lagos, Nigeria.

BACKGROUND: Despite the development of a safe and efficacious hepatitis B vaccine in 1982, the hepatitis B virus (HBV) remains a public health burden in sub-Saharan Africa. Due to shared risk factors for virus acquisition, men who have sex with men (MSM) and transgender women (TGW) living with HIV are at increased risk of HBV. We estimated the prevalence of HBV and associated factors for MSM and TGW living with or without HIV in Nigeria. METHODS: Since March 2013, TRUST/RV368 has recruited MSM and TGW in Abuja and Lagos, Nigeria using respondent driven sampling. Participants with HIV diagnosis, enrollment as of June 2015, and available plasma were selected for a cross-sectional study and retrospectively tested for hepatitis B surface antigen and HBV DNA. Logistic regression models were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for factors associated with prevalent HBV infection. RESULTS: A total of 717 MSM and TGW had a median age of 25 years (interquartile range [IQR]: 21-27), 5% self-reported HBV vaccination, 61% were living with HIV, 10% had prevalent HBV infection and 6% were HIV-HBV co-infected. HIV mono-infected as compared to HIV-HBV co-infected had a higher median CD4 T cell count [425 (IQR: 284-541) vs. 345 (IQR: 164-363) cells/mm3, p = 0.03] and a lower median HIV RNA viral load [4.2 (IQR: 2.3-4.9) vs. 4.7 (IQR: 3.9-5.4) log10copies/mL, p < 0.01]. The only factor independently associated with HBV was self-report of condomless sex at last anal intercourse (OR: 2.2, 95% CI: 1.3, 3.6). HIV infection was not independently associated with HBV (OR: 1.0, 95% CI: 0.7-1.6). CONCLUSION: HBV prevalence was moderately high but did not differ by HIV in this cohort of MSM and TGW. Recent condomless sex was associated with elevated HBV risk, reinforcing the need to increase communication and education on condom use among key populations in Nigeria. Evaluating use of concurrent HIV antiretroviral therapy with anti-HBV activity may confirm the attenuated HBV prevalence for those living with HIV.

Generating evidence for health policy in challenging settings: lessons learned from four prevention of mother-to-child transmission of HIV implementation research studies in Nigeria.

BACKGROUND: Implementation research (IR) facilitates health systems strengthening and optimal patient outcomes by generating evidence for scale-up of efficacious strategies in context. Thus, difficulties in generating IR evidence, particularly in limited-resource settings with wide disease prevention and treatment gaps, need to be anticipated and addressed. Nigeria is a priority country for the prevention of mother-to-child transmission of HIV (PMTCT). This paper analyses the experiences of four PMTCT IR studies in Nigeria, and proffers solutions to major challenges encountered during implementation. STUDIES INCLUDED AND FINDINGS: Multicentre PMTCT IR studies conducted in Nigeria during the Global Plan's assessment period (2011 to 2015) were included. Four studies were identified, namely The Baby Shower Trial, Optimizing PMTCT, MoMent and Lafiyan Jikin Mata. Major common challenges encountered were categorised as 'External' (beyond the control of study teams) and 'Internal' (amenable to rectification by study teams). External challenges included healthcare worker strikes and turnover, acts and threats of ethnic and political violence and terrorism, and multiplicity of required local ethical reviews. Internal challenges included limited research capacity among study staff, research staff turnover and travel restrictions hindering study site visits. Deliberate research capacity-building was provided to study staff through multiple opportunities before and during study implementation. Post-study employment opportunities and pathways for further research career-building are suggested as incentives for study staff retention. Engagement of study community-resident personnel minimised research staff turnover in violence-prone areas. CONCLUSIONS: The IR environment in Nigeria is extremely diverse and challenging, yet, with local experience and anticipatory planning, innovative solutions can be implemented to modulate internal challenges. Issues still remain with healthcare worker strikes and often unpredictable insecurity. There is a dire need for cooperation between institutional review boards across Nigeria in order to minimise the multiplicity of reviews for multicentre studies. External challenges need to be addressed by high-level stakeholders, given Nigeria's crucial regional and global position in the fight against the HIV epidemic.

Correlates of facility delivery for rural HIV-positive pregnant women enrolled in the MoMent Nigeria prospective cohort study.

BACKGROUND: Low rates of maternal healthcare service utilization, including facility delivery, may impede progress in the prevention of mother-to-child transmission of HIV (PMTCT) and in reducing maternal and infant mortality. The MoMent (Mother Mentor) study investigated the impact of structured peer support on early infant diagnosis presentation and postpartum maternal retention in PMTCT care in rural Nigeria. This paper describes baseline characteristics and correlates of facility delivery among MoMent study participants. METHODS: HIV-positive pregnant women were recruited at 20 rural Primary Healthcare Centers matched by antenatal care clinic volume, client HIV prevalence, and PMTCT service staffing. Baseline and delivery data were collected by participant interviews and medical record abstraction. Multivariate logistic regression with generalized estimating equation analysis was used to evaluate for correlates of facility delivery including exposure to structured (closely supervised Mentor Mother, intervention) vs unstructured (routine, control) peer support. RESULTS: Of 497 women enrolled, 352 (71%) were between 21 and 30 years old, 319 (64%) were Christian, 245 (49%) had received secondary or higher education, 402 (81%) were multigravidae and 299 (60%) newly HIV-diagnosed. Delivery data was available for 445 (90%) participants, and 276 (62%) of these women delivered at a health facility. Facility delivery did not differ by type of peer support; however, it was positively associated with secondary or greater education (aOR 1.9, CI 1.1-3.2) and Christian affiliation (OR 1.4, CI 1.0-2.0) and negatively associated with primigravidity (OR 0.5; 0.3-0.9) and new HIV diagnosis (OR 0.6, CI 0.4-0.9). CONCLUSIONS: Primary-level or lesser-educated HIV-infected pregnant women and those newly-diagnosed and primigravid should be prioritized for interventions to improve facility delivery rates and ultimately, healthy outcomes. Incremental gains in facility delivery from structured peer support appear limited, however the impact of duration of pre-delivery support needs further investigation. Religious influences on facility delivery and on general maternal healthcare service utilization need to be further explored. TRIAL REGISTRATION: ClinicalTrials.gov number NCT01936753 , registered September 2013.

Correlates of self-reported and biomarker based adherence to daily oral HIV pre-exposure prophylaxis among a cohort of predominantly men who have sex with men in Nigeria.

INTRODUCTION: HIV pre-exposure prophylaxis (PrEP) significantly reduces the risk of HIV acquisition. However, studies have demonstrated discordance between self-reported measures and biomedical benchmarks of PrEP adherence. We estimated the correlation between self-reported PrEP adherence and PrEP biomarkers and explored factors associated with adherence among men who have sex with men (MSM) in Nigeria. METHODS: TRUST-PrEP, an open-label, prospective study; conducted in Abuja between April 2018 and May 2019. MSM ≥ 18 years with substantial HIV risk were enrolled. Participants reported PrEP adherence in the last month using a 4-point scale from "poor" to "perfect" and serum samples for PrEP biomarkers were collected at months 3 and 9. Serum tenofovir concentration was measured by liquid chromatography-tandem mass spectrometry and considered protective for adherence if ≥ 4.2 ng/ml. Spearman's rank correlation was used to estimate correlation between self-reported adherence and measured tenofovir levels. Generalized estimating equations with a logit link was used to estimate adjusted odds ratios (aORs) and 95% confidence intervals (CIs) for associations between self-reported adherence and laboratory-measured adherence. RESULTS: A total of 219 MSM with median age 23 (interquartile range 20-27) years had at least one PrEP biomarker assay. Only 66/219 (30%) had at least one record of protective tenofovir concentration. Correlation between tenofovir and self-reported adherence at 3 and 9 months were 0.1 and 0.02 respectively. Furthermore, 17/219 (8%,) and 49/219 (22%) had serum tenofovir of 4.2-35.4 ng/mL and ≥ 35.5 ng/mL, corresponding to at least 4 and 7 days' PrEP use in a week, respectively. PrEP adherence was higher among participants introduced to PrEP in the clinics compared with communities (aOR: 8.35, 95%CI: [3.24, 21.5]) and those with same-sex practices family disclosure (aOR: 3.60 95% CI: [1.73, 7.51]). CONCLUSION: Self-reported PrEP adherence poorly correlated with biomarkers. Facilitating clinic-based PrEP introduction and disclosure of same-sex practices to family among MSM may improve PrEP adherence.

Evaluating Religious Influences on the Utilization of Maternal Health Services among Muslim and Christian Women in North-Central Nigeria.

INTRODUCTION: Uptake of antenatal services is low in Nigeria; however, indicators in the Christian-dominated South have been better than in the Muslim-dominated North. This study evaluated religious influences on utilization of general and HIV-related maternal health services among women in rural and periurban North-Central Nigeria. MATERIALS AND METHODS: Targeted participants were HIV-positive, pregnant, or of reproductive age in the Federal Capital Territory and Nasarawa. Themes explored were utilization of facility-based services, provider gender preferences, and Mentor Mother acceptability. Thematic and content approaches were applied to manual data analysis. RESULTS: Sixty-eight (68) women were recruited, 72% Christian and 28% Muslim. There were no significant religious influences identified among barriers to maternal service uptake. All participants stated preference for facility-based services. Uptake limitations were mainly distance from clinic and socioeconomic dependence on male partners rather than religious restrictions. Neither Muslim nor Christian women had provider gender preferences; competence and positive attitude were more important. All women found Mentor Mothers highly acceptable. CONCLUSION: Barriers to uptake of maternal health services appear to be minimally influenced by religion. ANC/PMTCT uptake interventions should target male partner buy-in and support, healthcare provider training to improve attitudes, and Mentor Mother program strengthening and impact assessment.

The impact of mentor mother programs on PMTCT service uptake and retention-in-care at primary health care facilities in Nigeria: a prospective cohort study (MoMent Nigeria).

BACKGROUND: Nigeria is a key target country in the global effort toward elimination of mother-to-child transmission of HIV. Low coverage of prevention of mother-to-child transmission (PMTCT) interventions, adherence, and retention-in-care rates in HIV-positive pregnant women are contributing factors to high mother-to-child transmission of HIV (MTCT) rates. In Nigeria, rural areas, served largely by primary health care facilities, have particularly poor indicators of PMTCT coverage. Mentor Mothers are HIV-positive women who serve as peer counselors for PMTCT clients, provide guidance, and support in keeping appointments and promoting antiretroviral adherence and retention-in-care. The Mother Mentor (MoMent) study aims to investigate the impact of structured Mentor Mother programs on PMTCT outcomes in rural Nigeria. DESIGN AND METHODS: A prospective cohort study will compare rates of retention-in-care among PMTCT clients who are supported by formally-trained supervised Mentor Mothers versus clients who receive standard-of-care, informal peer support. Study sites are 20 primary health care centers (10 intervention, 10 control) in rural North-Central Nigeria. The study population is HIV-positive mothers and exposed infant pairs (MIPs) (N = 480; 240 MIPs per study arm). Primary outcome measures are the proportion of exposed infants receiving early HIV testing by age 2 months, and the proportion of MIPs retained in care at 6 months postpartum. Secondary outcome measures examine antiretroviral adherence, 12-month postpartum MIP retention, and MTCT rates. This article presents details of the study design, the structured Mentor Mother programs, and how their impact on PMTCT outcomes will be assessed.