CBD of injectibles: studies, pilot programs evaluate effectiveness, safety of approach.

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 Asociaci6n 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 t998 by FHI and the Bolivian Center for Research, Education and Services in Sexual and Reproductive Health (Centro de Investigacion, Educacion 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 curriculum (9) 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 at http://www.fbi.org/en/fp/checklistse/chklstfpe/ index.html.) 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 Montufar, 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. Montufar. "The migrant woman must take each dose of DMPA to be administered by an APROFAM volunteer promoter or MOH staff member."

Like other family planning providers, CBD workers cannot be effective without a consistent supply of contraceptives. Dr. Montfifar 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 (see article, page 14) 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 CBD of 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."

REFERENCES

(1.) Fernandez VH, Montufar 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 Faro Plann 2002;33(2):141-64.

(2.) Phillips.

(3.) Haaga JG, Maru RM. The effect of operations research on program changes in Bangladesh. Stud Faro Plann 1996;27(2):76-87; Caldwell P, Caldwell J. What does the Matlab fertility experience really show? Stud Faro Plann 1992;23(5):292-310.

(4.) Debpuur; Asuru R, Phillips JE 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.) Fernandez.

(6.) Leon 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, Lopez ME, Johnson S, et al. Salud Sexual y Salud Reproductiva: Guia para Promotores. Modulo: Depo Provera. La Paz, Bolivia: Centro de Invesfigacitn, Educaci6n y Servicios, CARE, and Family Health International, 1998.

(10.) Family Health International. Provider Checklists for Reproduaive 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 I. Chapel Hill, NC: Intrah, 1995.

(13.) Fernandez.

(14.) Aronovich D. Best practices 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.