Depo-SubQ Provera (medroxyprogesterone acetate) / Pfizer - LARVOL DELTA

Alleviating price and information barriers to long-acting contraception uptake in Kenyan pharmacies using patient and provider incentives: a cluster randomized control trial. (PubMed, EClinicalMedicine) - "This study highlights the potential of a novel payment and incentive structure for pharmacies, a key access point for contraceptives for young women in particular, to improve access to subcutaneous depot medroxyprogesterone acetate (DMPA-SC)...This study was funded by the Children's Investment Fund Foundation and The Weiss Fund for Research in Development Economics at the University of Chicago. This study was prospectively registered with the AEA registry for randomized controlled trials (AEARCTR-0009020) and is registered with the Pan-African Clinical Trials Network (PACTR202506634961987)."

Journal • Women's Health

Understanding clients' and providers' perspectives on the implementation of subcutaneous depot medroxyprogesterone acetate (DMPA-SC) for self-injection programming in Nigeria. (PubMed, BMJ Glob Health) - "Occasionally, providers used clients' age or education to decide whether they could self-inject independently, rather than clients' ability to perform SI procedures, limiting client-centredness Many providers felt their fidelity to SI provision protocols could improve with refresher trainings on the latest guidelines around offering SI. Clients indicated that proactive follow-up support from providers for continued SI and side effect management was appropriate and desired; providers concurred with offering such support.Findings suggest that programme scale-up efforts should prioritise: (1) leveraging peer support or social networks to facilitate acceptability of DMPA-SC for SI among clients, (2) improving access to training aids to ensure fidelity to protocols and facilitate adoption among clients and providers, (3) emphasising shared decision-making in judgement-free client trainings to encourage client-centredness, and (4) investing in models for proactive..."

Journal • Infectious Disease • Long-acting Reversible Contraceptives

Continuation of Subcutaneous and Intramuscular Depot Medroxyprogesterone Acetate in Post-abortion Patients (clinicaltrials.gov) - P4 | N=263 | Completed | Sponsor: Northwestern University | Recruiting ➔ Completed | N=653 ➔ 263

Enrollment change • Trial completion

Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone (clinicaltrials.gov) - P4 | N=35 | Completed | Sponsor: University of Colorado, Denver | Recruiting ➔ Completed

Trial completion • CNS Disorders

Barriers and Facilitators to Expanding User-Administered Injectable Contraceptives in the United States. (PubMed, O G Open) - "Our data among experts in contraceptive care highlight that awareness is associated by professional- and institutional-level factors and barriers between awareness of subcutaneous DMPA for user administration and provision that are primarily institutional and systemic. Facilitators for awareness and provision of subcutaneous DMPA for self-administration span multiple domains, including professional's perceived patient barriers, professional demographics, institutional challenges, and government policies."

Journal • Gynecology • Long-acting Reversible Contraceptives • Obstetrics

Challenges to informed choice counselling: a qualitative study of contraceptive self-care introduction in the Copperbelt Province of Zambia. (PubMed, BMJ Glob Health) - "Findings reveal the importance of reinforcing informed choice principles and monitoring the quality of contraceptive counselling when introducing new contraceptive methods and self-care innovations."

Journal

Return to fertility after subcutaneous depot medroxyprogesterone acetate: a narrative review. (PubMed, BMJ Sex Reprod Health) - "Median time to ovulation for DMPA SC 104 mg of 212 days was similar to that of DMPA IM 150 mg of 183 days, suggesting that choice of formulation (SC vs IM) does not impact the timeline for return to fertility."

Journal • Review • Gynecology • Infertility • Sexual Disorders

Providing contraception to trans youth: a qualitative study investigating the acceptability of DMPA-SC and prior experiences with contraceptive counseling. (PubMed, J Pediatr Adolesc Gynecol) - "The SRH needs of TGD individuals differ from their cisgender counterparts. Historically, the primary endpoint for contraceptive studies focused on preventing pregnancies. Assuming this as the primary goal for TGD individuals can be harmful to the provider-patient relationship and lead to avoidance of care. When providing contraceptives at the intersection of gender identity and sexual orientation, counseling should be tailored towards an individual's unique SRH needs."

Journal • CNS Disorders • Women's Health

Acceptability and effectiveness of empathy-based provider training and community-level awareness activities on self-injectable contraceptive use in Niger, Lagos, and Oyo States, Nigeria: a mixed methods program evaluation. (PubMed, BMC Womens Health) - "Our findings demonstrate the effectiveness and acceptability of a program combining supply- and demand-side interventions aimed at expanding awareness and access to self-injectable contraception in Nigeria. In this context, providers highly valued in-service training and ongoing support that built capacity for empathetic client engagement."

Journal • Long-acting Reversible Contraceptives

Injectable contraceptive continuation and user experiences in Punjab, Pakistan: a non-randomized prospective cohort study protocol. (PubMed, BMC Womens Health) - P | "This research offers an opportunity to contribute to global efforts to reduce inequities in access to contraceptive method choices, while generating actionable evidence to inform health sector decision-making in Pakistan. Although study sites are limited to health facilities where a woman's first self-injection of DMPA-SC is supervised by a nurse, midwife, medical officer, Lady Health Visitor, Family Welfare Worker or Family Welfare Councilor, the research protocol and findings will provide a foundation for future studies testing alternative service provision and self-injection support models."

Journal • Long-acting Reversible Contraceptives

Lessons from the scale-up of provider-administered and self-injection of DMPA-SC in Nigeria: a landscape assessment. (PubMed, BMC Womens Health) - "This assessment illustrates the influence of an enabling environment and stakeholder commitment on the positive trend in provider-administered and self-injection DMPA-SC uptake in Nigeria. Training service providers and improving funding through the use of innovative financing were recommended as levers for DMPA-SC programme sustainability and service scale-up."

Journal

Quality of counseling for self-administering injectable contraception: field evidence from mystery client interactions in Lagos, Nigeria. (PubMed, BMC Womens Health) - "Willingness to dispense DMPA-SC for SI differed by facility type but not by client profile. However, younger, unmarried profile actors experienced more scrutiny from providers. These findings indicate a need for clarifying service provision protocols to ensure an enabling environment for women's access to and use of self-injectable contraception."

Journal • Long-acting Reversible Contraceptives

Factors associated with the acceptability of self-injection training by clients receiving DMPA-SC services from community pharmacies and patent and proprietary medicine vendors in Nigeria. (PubMed, BMC Womens Health) - "The results are promising for expanding DMPA-SC self-injection service delivery in Nigeria through increased method choice, and empowered users. The provision of counseling and DMPA-SC self-injection training by CPs and PPMVs is acceptable among women in Lagos and Kaduna states."

Journal

Comparative pharmacokinetics and safety of subcutaneous and intramuscular depot medroxyprogesterone acetate when used among women living with HIV on doravirine-containing antiretroviral therapy (IAS-HIV 2025) - "A formulation of subcutaneous depot medroxyprogesterone acetate (SC MPA, 104mg, i.e., Sayana Press), dosed lower than intramuscular (IM) DMPA (150mg), is available commercially. The data provides valuable insights into the pharmacokinetics and safety of SC MPA and IM DMPA in WLWH using and doravirine-containing ART. While MPA concentrations were lower in the SC MPA vs. IM DMPA groups, as expected, there was no significant impact on ART concentrations providing a signal of limited drug-drug interactions."

Clinical • PK/PD data • Human Immunodeficiency Virus • Infectious Disease • Long-acting Reversible Contraceptives

Knowledge, confidence and social support: Kenyan women's priority needs for contraceptive self-injection learning through a social cognitive theory lens. (PubMed, BMC Womens Health) - "Our study highlights Kenyan women's desire for a contraceptive SI learning experience that imparts knowledge through comprehensive counseling and instills confidence through observational learning from healthcare providers and ample practice opportunities until the users feel ready to self-inject at home. By aligning with the WHO self-care guidelines and leveraging the social cognitive theory, client training programs can equip women to adopt SI confidently should they so choose."

Journal • Long-acting Reversible Contraceptives

A longitudinal study examining how self-injection social norms are associated with contraceptive self-injectable interest and use in rural Uganda. (PubMed, BMC Womens Health) - "The Self-injection Social Norms Scale is a new 4-item measure that can be used by researchers and program implementors. Our finding that social norms related to self-injection are associated with women's interest in, and subsequent use of, self-injectable contraception suggest that promoting supportive social norms around self-injection shows potential as one strategy to enhance programmatic work aimed at bolstering women's ability to choose this method if it aligns with their preferences."

Journal • Observational data • Long-acting Reversible Contraceptives

Adolescent Subcutaneous (SQ) Injection Video Validation (clinicaltrials.gov) - P=N/A | N=30 | Active, not recruiting | Sponsor: Tufts Medical Center | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed

How do pro-social tendencies and provider biases affect service delivery? Evidence from the rollout of self-injection of DMPA-SC in Nigeria. (PubMed, BMC Womens Health) - "Provider biases may limit provision of DMPA-SC for SI, which could affect contraceptive equity and women's control over their own fertility, especially for younger, unmarried women. Targeted interventions that effectively address provider biases against young, unmarried women, potentially leveraging providers' underlying pro-social tendencies, may help ensure equity in client access to contraceptive self-care."

Journal

Examining the relationship between reproductive empowerment and contraceptive self-injection: Tackling the endogeneity problem. (PubMed, PLoS One) - "We did not find evidence of a significant relationship between reproductive empowerment and desire to continue self-injecting. Though there are limitations to this secondary data analysis, we recommend future research investigate this relationship using the methodology demonstrated to address endogeneity inherent in answering this critical question about self-care interventions."

Journal

Women's Perspectives on the Unique Benefits and Challenges of Self-Injectable Contraception: A Four-Country In-Depth Interview Study in Sub-Saharan Africa. (PubMed, Stud Fam Plann) - "Implementing self-injection (SI) of subcutaneous depot-medroxyprogesterone acetate (DMPA-SC) is a key self-care strategy for sexual and reproductive health, but SI uptake remains low, and assertions about the potential of SI to increase women's control over contraceptive use lack evidence...Interviews revealed SI's potential is, however, constrained by inherent limitations in the method; for example, it is often not private or accessible enough and many fear injecting themselves. SI has the most potential when implemented with programmatic solutions that mitigate challenges women experience or anticipate and allow more women to benefit from the privacy, easier access, and self-management that SI offers."

Interview • Journal • Long-acting Reversible Contraceptives

Novel dissolution methods for drug release testing of Long-Acting injectables. (PubMed, Int J Pharm) - "These adapters were validated and assessed using the long-acting injectable (LAI) suspension drug product Depo Provera 150® as well as its Q1/Q2 equivalents...A successful Level A IVIVC was developed for Depo SubQ Provera 104® and its Q1Q2 equivalents using USP apparatus type IV with a conical adapter design. The closed adapter design for apparatus type-II was also investigated for suitability with risperidone in situ forming implants. The adapter was able to securely retain and maintain the shape of the in situ forming implants and resulted in release profiles of up to one month with good discriminatory ability and low standard error (RSD≤5%). These novel adapters hold promise of wide use for in vitro release testing of different long-acting parenteral drug products."

Journal

Digital training for self-injectable contraceptives: a feasibility and acceptability pilot study. (PubMed, BMJ Sex Reprod Health) - "Training participants to administer self-injectable contraceptives via WhatsApp video call was feasible and acceptable. Training lessons learnt offer pragmatic adaptations for communicating about a practical skill via a digital channel. Further research is needed to ascertain the efficacy of digital training for self-injection and feasibility and acceptability for wider groups."

Journal • Long-acting Reversible Contraceptives

EPIC: Evaluation of Pharmacokinetic Drug-drug Interactions Between Hormonal Contraceptives and Doravirine-containing ART Among Women Living With HIV in South Africa (clinicaltrials.gov) - P4 | N=108 | Completed | Sponsor: University of Alabama at Birmingham | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Feb 2024 | Trial primary completion date: Jun 2024 ➔ Feb 2024

Trial completion • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: University of Colorado, Denver | Trial completion date: Jun 2024 ➔ Jun 2027 | Trial primary completion date: Dec 2023 ➔ Dec 2026

Trial completion date • Trial primary completion date • CNS Disorders

Development of Mechanistic In Vitro-In Vivo Extrapolation to Support Bioequivalence Assessment of Long-Acting Injectables. (PubMed, Pharmaceutics) - "The objectives of this study were as follows: (1) to use a mechanistic modeling approach to delineate the in vivo performance of DepoSubQ Provera® and formulation variants in preclinical species; (2) to predict human exposure based on the knowledge gained from the animal model. The PBPK model evaluated different elements involved in LAI administration and showed that (1) the effective in vivo particle size is potentially larger than the measured in vitro particle size, which could be due to particle aggregation at the injection site, and (2) local inflammation is a key process at the injection site that results in a transient increase in depot volume. This work highlights how a mechanistic modeling approach can identify critical physiological events and product attributes that may affect the in vivo performance of LAIs."

Journal • Preclinical • Inflammation