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FHI's Quarterly Health Bulletin Network

CBD of Injectables

Studies, pilot programs evaluate effectiveness, safety of approach. 

Network: 2003, Vol. 22, No. 3

NetworkCopyright Family Health International, 2003. 
Network is reprinted with permission from Family Health International.

Training health workers and volunteers to provide injectable contraceptives in their communities can improve access to this popular, highly effective method and attract new contraceptive users.1 While community-based distribution (CBD) of injectables has been limited, in part because of concerns about safety, experience suggests that well-trained CBD workers can administer injectables safely.

The impact of CBD of injectables has been investigated in a few studies in Asia and sub-Saharan Africa and is increasingly being tested in various settings in Latin America.

The most extensive efforts to provide injectables in communities began in 1976 as part of a project by the International Center for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) in Matlab, Bangladesh. The project trained literate, married women to offer counseling with the progestin-only injectable depot-medroxyprogesterone acetate (DMPA) — and other contraceptives — in clients' homes. The project also provided a strong referral system. From 1977 to 1985, when 40 percent of contraceptive users in Matlab chose DMPA, the fertility rate in the area declined by 25 percent compared with rates in other study areas, where DMPA use was rare.2 A higher contraceptive prevalence in Matlab than in the rest of rural Bangladesh was largely attributable to DMPA use.3 Bangladesh's experience showed that injectables "are enormously popular when you put them at the doorstep," says Dr. James Phillips, a Population Council senior associate who has conducted research on the Matlab project and other family planning programs in Bangladesh.

In communities in northern Ghana, CBD of injectables was also found to have a substantial impact on fertility levels. A study conducted by the Navrongo Community Health and Family Planning Project was not specifically designed to assess the effect of introducing community access to injectables, but the overwhelming majority of clients — 92 percent — chose DMPA from the range of methods offered by nurses during home visits. In three years, births per woman had been reduced by one in the communities receiving CBD of contraception by nurses and promotion of family planning by community volunteers. This represented a 16 percent decline compared with fertility levels in similar communities served by standard Ministry of Health (MOH) services.4

Meanwhile, governmental agencies and nongovernmental organizations (NGOs) in Latin America are beginning to expand efforts to provide injectables through CBD workers:

  • The Guatemalan family planning association Asociación Pro-Bienestar de la Familia de Guatemala (APROFAM) added CBD of injectables to its programs in all the country's 22 departments after a study by APROFAM and the New York-based Population Council showed that this approach was as effective as clinic provision of DMPA in attracting new contraceptive users and achieving high continuation rates. CBD of DMPA proved a particularly effective strategy for increasing access to injectable contraception among rural, primarily indigenous women in Guatemala: 83 percent of the 500 Mayan clients received DMPA services from community-based educators and volunteers, compared with half of 692 women of European ancestry who participated in the study.5
  • A study of the introduction of DMPA through MOH services and the CARE CBD program in Peru, conducted by the Population Council and the Andean Institute of Population and Development Studies, demonstrated that community-based volunteers could provide DMPA safely and reach clients not served by MOH health workers.6
  • In Mexico, a large introductory study of the monthly combined injectable contraceptive Cyclofem included community-based provision to women in rural areas. CBD workers actually achieved a higher continuation rate than MOH staff: 37 percent of the 640 rural women served by CBD workers were still using Cyclofem after one year, compared with 24 percent of the 2,817 urban and suburban women who visited health centers.7
  • In Bolivia, community-based injectable services in a small acceptability study, conducted in 1998 by FHI and the Bolivian Center for Research, Education and Services in Sexual and Reproductive Health (Centro de Investigación, Educación y Servicios, or CIES) in El Alto, achieved high DMPA continuation rates. Only four women discontinued during the study, and three of the four resumed using DMPA with the help of CBD workers. Half of the 29 users recruited for this study chose to receive subsequent injections from a CBD worker.8 CBD workers in El Alto continue to distribute injectables, and CIES plans to expand this service to Santa Cruz and Cochabamba in 2003.

FHI plans to adapt the CBD training curriculum9 it developed with CIES and CARE in Bolivia for use in a study of the safety and feasibility of community-based injection services in Uganda. "The Bolivian study, as well as the experience of the Population Council and others, showed that CBD provision of DMPA was feasible, and that FHI's screening checklist — to help nonclinic-based providers determine women's eligibility for DMPA use — and a good curriculum could facilitate the process," says Dr. John Stanback, an FHI senior associate. "The time is right to do a rigorous study in Africa designed to respond to the technical and logistical objections that prevent access to this popular method."

CBD challenges

Technical concerns about CBD of injectables include doubts about CBD workers' ability to screen properly any potential injectable users, counsel them, meet injection schedules, and follow appropriate procedures for disposing of used needles and syringes. Logistical concerns address the ability of CBD programs to maintain a consistent supply of contraceptives and injection equipment and to provide adequate medical support for women with side effects. All programs that provide injectables face these challenges, however.

Concerns that CBD workers will not be able to recognize medical conditions that might contraindicate their provision of DMPA — such as a history of stroke, blood clot in the legs or lungs, or heart attack — are addressed in part by the updated checklist that FHI developed and field tested for the Technical Guidance/Competence Working Group of the U.S. Agency for International Development (USAID).10 The checklist is available in English, Spanish, and French. An FHI study in Nepal found that medical conditions that would contraindicate DMPA provision by CBD workers were rare and would have been easily identified by use of the checklist.11 Reassured by these findings, the U.S. NGOs CARE and Save the Children, USA, are working with Nepal's MOH to revise training materials (developed and tested by Save the Children) to prepare CBD workers to provide DMPA under the USAID-funded Nepal Family Health Program.

Another frequent concern is that CBD workers may not provide clients with counseling that will sufficiently prepare them for bleeding problems that are a common side effect of injectable contraceptives. "Providers tend to gloss over the side effects, particularly the amenorrhea, and clients become unnecessarily worried that they might be pregnant, and they discontinue," explains Dr. Stanback. But CBD workers can be trained to counsel clients effectively, says Population Council consultant Dr. Edwin Montúfar, who attributes the high continuation rate achieved by APROFAM's community-based injectables services to thorough training, high-quality counseling, and regular supervision through monthly visits to APROFAM's volunteers.

In CBD programs, community-based agents are responsible for reaching clients at the right time. "CBD workers would have to adhere to a tight schedule for home visits," Dr. Stanback says. "Clients are supposed to get their shots every three months, and CBD agents will have to ensure that their visits fall within the relatively narrow window of opportunity."

Clients do have a "grace period," he adds, but it is important to ensure that a woman is not left without any contraceptive protection, such as condoms, if a CBD worker arrives a few days after the scheduled injection date. The World Health Organization and USAID's Technical Guidance/Competence Working Group determined that DMPA can be given up to four weeks early (though not ideal) or up to two weeks late and possibly up to four weeks late, depending on the population. (Some populations, such as women from Southeast Asia, seem to metabolize DMPA more slowly than others, so that the contraceptive effect may last longer than three months.)12

Sometimes even the most conscientious CBD worker may be unable to locate a client. The most common reason for discontinuation of Cyclofem in Mexico was change of address. Seasonal migration for work was one of the main reasons for discontinuation of DMPA in a small CBD pilot study in Guatemala.13 APROFAM addressed this problem by selling one or two doses of DMPA to women who planned to migrate for part of the year. "There are people trained to administer DMPA throughout the country," explains Dr. Montúfar. "The migrant woman must take each dose of DMPA to be administered by an APROFAM volunteer promoter or MOH staff member."

Gus Osorio/JSI DELIVER

An empty bin reminds community-based workers in Africa to get more supplies.

Like other family planning providers, CBD workers cannot be effective without a consistent supply of contraceptives. Dr. Montúfar says an important element in APROFAM's success with CBD of injectables is its strong logistics system, which also supplies other Guatemalan NGOs that provide family planning services. DELIVER, John Snow Inc.'s USAID-funded health commodity logistics project, recommends a simple system that has been used to resupply CBD workers in Africa. Each CBD worker receives two bins filled with the same set of contraceptive supplies. When the first bin is empty, a CBD worker knows it is time to turn it in for new supplies.14

Reducing risk

Syringes that automatically become disabled after a single use address an overriding concern for both clinic and CBD programs: the risk of spreading infection, including HIV and hepatitis B, through unsterilized or improperly sterilized injection equipment. These syringes greatly reduce that risk because they are designed to preclude reuse.15

Dr. Stanback hopes that the increasing availability of DMPA in single-use syringes such as SoloShot FX will help reduce opposition — based on safety concerns — to CBD injectable services. However, many medical professionals remain reluctant to cede responsibility for the provision of injectable contraceptives to paramedical or nonmedical personnel.

FHI is working with Ugandan health officials to design a study that will address concerns about the safety of CBDof injectables. The proposed research design calls for an assessment of trained CBD workers' ability to give injections safely in clinics before deciding whether to provide community-based services. Evaluation of that second phase would include an expert assessment of the pilot project and comparisons of continuation rates, injection site infections, user satisfaction, and client recall of key information among new DMPA users served in clinics and those served by the CBD workers.16 "We hope it will be a model for the continent," Dr. Stanback says.

Providing community-based injectable services in sub-Saharan Africa is important because it is the only way some women will have access to one of the most popular methods in the region, Dr. Stanback adds. "Most populations in Africa very much want injectables," he says. "Those who do not have access to clinic services will really miss out."

— Kathleen Henry Shears

References

  1. Fernández VH, Montúfar E, Ottolenghi E. Injectable contraceptive service delivery provided by volunteer community promoters. Unpublished paper. Population Council, 1997; Phillips JF, Hossain MB, Huque AA, et al. A case study of contraceptive introduction: domiciliary depot-medroxyprogesterone acetate (DMPA) services in Bangladesh. In Segal S, Tsui AO, Rogers S, eds. The Demographic and Programmatic Consequences of New Contraceptives. New York, NY: Plenum Press, 1989; Debpuur C, Phillips JF, Jackson EF, et al. The impact of the Navrongo project on contraceptive knowledge and use, reproductive preferences, and fertility. Stud Fam Plann 2002;33(2):141-64.
  2. Phillips.
  3. Haaga JG, Maru RM. The effect of operations research on program changes in Bangladesh. Stud Fam Plann 1996;27(2):76-87; Caldwell P, Caldwell J. What does the Matlab fertility experience really show? Stud Fam Plann 1992;23(5):292-310.
  4. Debpuur; Asuru R, Phillips JF, Akumah I, et al. The success and failure of alternative strategies for community-based distribution of contraception in the Navrongo Project. American Public Health Association 130th Annual Meeting, Philadelphia, PA, November 9-13, 2002.
  5. Fernández.
  6. León F. Utilizing operations research solutions: a case study in Peru. Unpublished paper. Population Council, 2001.
  7. Garza-Flores J, Del Olmo AM, Fuziwara JL, et al. Introduction of Cyclofem once-a-month injectable contraceptive in Mexico. Contraception 1998;58(1):7-12.
  8. McCarraher D, Bailey P. Bolivia: Depo-Provera provision by community based distribution workers and other CIES staff in El Alto. Unpublished paper. Family Health International, 2000.
  9. Zuna OV, López ME, Johnson S, et al. Salud Sexual y Salud Reproductiva: Guía para Promotores. Módulo: Depo Provera. La Paz, Bolivia: Centro de Investigación, Educación y Servicios, CARE, and Family Health International, 1998.
  10. Family Health International. Provider Checklists for Reproductive Health Services Reference Guide. Research Triangle Park, NC: Family Health International, 2002.
  11. Rai C, Thapa S, Bhattarai L, et al. Conditions in rural Nepal for which depot medroxyprogesterone acetate initiation is not recommended: implications for community based service delivery. Contraception 1999;60(1):31-37.
  12. Curtis KM, Bright P, eds. Recommendations for Updating Selected Practices in Contraceptive Use: Results of a Technical Meeting. Volume 1. Chapel Hill, NC: Intrah, 1995.
  13. Fernández.
  14. Aronovich D. Best practices for health commodity logistics in CBD programs: ensuring product availability. Meeting on best practices in CBD programs in sub-Saharan Africa: lessons learned from research and evaluation, Washington, DC, December 2, 2002.
  15. Ekuwueme DU, Weniger BG, Chen RT. Model-based estimates of risks of disease transmission and economic costs of seven injection devices in sub-Saharan Africa. Bull WHO 2002;80(11):859-70.
  16. Stanback J. Safety and feasibility of DMPA provision by CBRH workers in Uganda. Unpublished paper. Family Health International, 2002.

The ongoing development of various single-use injection devices may make injectable contraceptive provision safer.

One such device is called SoloShot FX. Since September 2002, it has been packaged with all U.S. Agency for International Development (USAID) shipments of the three-month, progestin-only injectable depot-medroxyprogesterone acetate (DMPA). Developed by the U.S.-based Program for Appropriate Technology for Health (PATH) with support from USAID, SoloShot FX has a metal clip that locks the plunger after a single use and is packaged with a detachable needle that cannot be attached to any other type of syringe.1 To encourage safe disposal of used syringes, all USAID shipments of SoloShot FX and DMPA include a special container in which syringes, needles, and other contaminated materials can be discarded. Notably, SoloShot FX causes less pollution than most standard syringes when it is burned (after disposal), since it does not contain a black rubber piston seal.

 

BD (Becton, Dickinson and Company)

Both Uniject (above) and SoloShot FX (below) are designed to be used only once.
Another such device, also developed by PATH with support from USAID and commercially produced and distributed by U.S.-based BD (Becton, Dickinson and Company), is called Uniject. This plastic device houses hormones, needle, and syringe together in one small sealed pouch. Such an arrangement makes Uniject easy to transport outside of a clinic setting and particularly easy to administer, even by paramedical or trained nonmedical personnel. Like the SoloShot FX, Uniject was specifically designed so it could not be refilled or used again. An additional and important feature of Uniject is that it is prefilled with a single dose of hormones so the correct dose is always administered.

These new devices for injecting contraceptives address several concerns about, and barriers to, the use of injectable contraceptives, which more than 12 million women worldwide use. First, in some resource-poor settings or where contraceptive supplies are limited, needle reuse — which can put clients at risk for blood-borne infections such as HIV — sometimes occurs. The use of single-use injection devices would minimize this risk in both clinic and community-based distribution programs. Second, for many women, travel to clinics to receive injections is difficult and expensive.2 But community-based workers could more easily give injections if Uniject were available for them. "We see technologies like Uniject enhancing the ability to take interventions to clients through outreach activities — clients who would otherwise not be reached," says Steve Brooke, PATH senior program officer, business development and commercialization.

With support and technical assistance from the World Health Organization and PATH, the Universidade Estadual de Campinas (UNICAMP), Centro de Pesquisas das Doencas Materno-infantis de Campinas (CEMICAMP), Intrah, and colleagues evaluated in Brazil the administration of the one-month, combined injectable Cyclofem using Uniject versus standard syringes. A study including 20 registered and auxiliary nurses and 135 injectable users from five reproductive health clinics there showed that nurses could easily administer Cyclofem in the Uniject device.3 Ninety percent of the nurses said the device was easy to activate and inject, and all said it was easy to store and transport.

The same Brazilian study showed high rates of acceptability among users. Women in the study reported little pain during injections, and almost all said they would receive another Uniject injection. An additional study from Brazil showed that even self-administration was feasible and acceptable to some women: More than 90 percent of 56 injectable users were able to self-administer Uniject/Cyclofem correctly, and half said they wished to continue injecting the contraceptive themselves.4

A similar study has been conducted by public-sector agencies in Mexico; results are pending. In the meantime, the Mexican company Aplicaciones Farmaceúticas has acquired regulatory approval to sell Uniject/Cyclofem in the public and private sectors. The company plans to do so once it is certain that its high-volume manufacturing process will reliably meet demand for the product, says PATH's Brooke. The U.S.-based company Pharmacia is also considering the feasibility of Uniject as a delivery system for DMPA. Meanwhile, USAID is supporting the application of Uniject for the delivery of either Cyclofem or DMPA, and hopes to begin testing this approach in 2003.

— Kerry L. Wright and Kathleen Henry Shears

References

  1. HealthTech. Introducing Auto-Disable Syringes and Sharps Disposal Containers with DMPA. Seattle, WA: Program for Appropriate Technology in Health, 2001. Available: http://www.path.org/files/SI_CNVP15904_English.pdf.
  2. Bahamondes L, Marchi NM, Nakagava HM, et al. Self-administration with UniJect of the once-a-month injectable contraceptive Cyclofem. Contraception 1997;56(5):301-4.
  3. Bahamondes L, Marchi NM, de Lourdes Cristofoletti M, et al. Uniject as a delivery system for the once-a-month injectable contraceptive Cyclofem in Brazil. Contraception 1996;53(2):115-19.
  4. Bahamondes, Marchi, Nakagava.

 

A perception that progestin-only injectable use can increase vaginal wetness has been identified in two recent studies conducted in South Africa.1 In the two studies of side effects and reasons for discontinuation given by progestin-only injectable users there (where, in the early 1990s, the method accounted for up to 80 percent of contraceptive use2), menstrual disturbances were the most frequently mentioned side effects. But vaginal wetness emerged as another common — and undesirable — perceived side effect in a setting where "dry sex" is practiced, as it is in several parts of central and southern Africa.3

Notably, this perception is not supported by scientific evidence. No association between progestin-only injectable use and an increase in vaginal moisture has been documented. In fact, progestin-only injectable use would be expected to lower estrogen levels in users and, as a result, perhaps decrease vaginal moisture.4 Whether vaginal infections unrelated to contraception, such as bacterial vaginosis or trichomoniasis, contribute to the perception of increased wetness is also unknown. Until such information is available, any link between vaginal wetness and injectable progestin-only contraceptives remains speculative.

Nevertheless, providers need to be aware that a perceived association with vaginal wetness can affect the acceptability of progestin-only injectables and could lead to their discontinuation. In the first study, conducted in a rural district of KwaZulu-Natal, about a fifth of 187 users of progestin-only injectables reported vaginal wetness as a side effect and said that it was what they liked least about the contraceptive method. Both male and female participants in focus group discussions involving some 100 users and non-users associated injectable use with both vaginal wetness and lack of female sexual desire, two characteristics that many male participants equated with female promiscuity.5 In the second study, conducted at a family planning clinic in Soweto, Johannesburg, a fifth of 189 new users of progestin-only injectables mentioned vaginal discharge as a perceived side effect at least once. Almost all of the women said they were unhappy with the discharge, which they described as "watery," and three of the women gave it as the primary reason for discontinuing use.6

— Kerry L. Wright

References

  1. Smit J, McFadyen L, Zuma K, et al. Vaginal wetness: an underestimated problem experienced by progestogen injectable contraceptive users in South Africa. Soc Sci Med 2002;55(9):1511-22; Beksinska ME, Rees HV. Vaginal discharge: a perceived side effect and minor reason for discontinuation in hormonal injectable users in South Africa. Afr J Reprod Health 2001;5(3):84-88.
  2. Reproductive Health Task Force, South African Ministry of Health, World Health Organization. Assessment of reproductive health in South Africa: focusing on family planning. Unpublished report. Reproductive Health Task Force, South African Ministry of Health, and World Health Organization, 1994.
  3. Beksinska ME, Rees HV, Kleinschmidt I, et al. The practice and prevalence of dry sex among men and women in South Africa: a risk factor for sexually transmitted diseases? Sex Transm Infect 1999;75(3):178-80; Brown JE, Brown RC. Traditional intravaginal practices and the heterosexual transmission of disease. A review. Sex Transm Dis 2000;27(4):183-87; Brown JE, Ayowa OB, Brown RC. Dry and tight: sexual practices and potential AIDS risk in Zaire. Soc Sci Med 1993;37(8):989-94; Civic D, Wilson D. Dry sex in Zimbabwe and implications for condom use. Soc Sci Med 1996;42(1):91-98.
  4. Bahamondes L, Trevisan M, Andrade L, et al. The effect upon the human vaginal histology of the long-term use of the injectable contraceptive Depo-Provera. Contraception 2000;62(1):23-27; Miller L, Patton DL, Meier A, et al. Depomedroxyprogesterone-induced hypoestrogenism and changes in vaginal flora and epithelium. Obstet Gynecol 2000;96(3):431-39.
  5. Smit.
  6. Beksinska, Rees.

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